How do you help meet NIS2 and CRA requirements?

We offer a variety of training formats to meet the varying needs of our participants and clients. Some of them are:

instructor-led training courses
These can be held both on Location and online. On Location can be conducted at our premises, at one of our partners or directly at yours. Our online trainings are most often delivered via our LMS, Teams or Zoom, providing flexibility and access wherever you are.

Hybrid training courses
Combines the benefits of both on Location and online formats. This flexible solution offers participants the opportunity to choose whether to attend physically at Location or via a digital platform. Alternatively, the training can vary between having initial sessions at the Location and continuing with sessions online. This model is ideal for maximizing accessibility and adapting to participants' individual needs and circumstances.

E-learnings
Our e-learnings offer a wide variety of training content ranging from recorded sessions to microlearning. These courses are designed for self-study and participants can complete them at their own pace. By using our LMS platform, learners can access video lectures and take exams whenever they feel ready, giving them full control over their learning.

Interactive e-learning
This form of e-learning includes interactive elements such as quizzes, simulations, and practical exercises that actively engage participants in the learning process. These courses are specifically designed to increase interaction and understanding by involving participants in active tasks and decision-making. Our interactive e-learnings are available through our LMS platform and combine flexibility with a deeper learning experience.

Flipped Classroom
This pedagogical method inverts traditional learning activities by having participants first access learning materials, such as guidelines, instructions or e-learning courses, in advance. This preparatory work allows the instructor-led session, which can take place on Location at the customer's premises, to effectively utilize the time to deepen knowledge through targeted discussions and practical exercises that directly relate to the participants' specific challenges.
For example, several of our clients have appreciated first completing our eGAMP5 trainingfollowed by an Location workshop that focuses on applying the newly acquired knowledge in their unique work environment. This approach promotes active learning and ensures a deeper understanding of the subject.

Each format is designed to meet different learning needs and styles, ensuring that customers and participants can find a learning solution that suits them best.

Not at the moment, but we are working on designing interactive training for all our courses in e-learning format.

If you are missing a training course from our offer, please contact us with your request.

Yes, absolutely, we will develop a customized package for you and your team with selected training courses, where you as a manager can follow the progression and certifications of your employees.

Of course, we can arrange this via invoice. Please contact us at academy@plantvision.se or fill out our form at Customised courses, and we’ll get back to you with information on how we can assist you.

Everyone who completes a training course with us receives a certificate of completion that can be used professionally. For training through our partners, please refer to what is stated when purchasing through them.

Our Instructor and course developers are experts in their fields and keep up to date through industry collaboration, participation in relevant forums and networks, and continuous professional development. The trainers are also consultants and work hands-on with the tools and skills they teach.

Absolutely, contact plantvision for help identifying which training best suits your needs.

We can also help you design a training program that combines several courses to give you a more comprehensive skills development.

You can register on our website under the respective training page. Just select the course you are interested in and click on "BOOK" to go to our or our partner's registration page.

We offer both tailor-made and in-house training courses, adapted to your specific needs and requirements. You can choose to tailor the content of our existing open courses to suit your organization, or we can help you design a new course entirely.

To discuss your needs and get started, contact us at academy@plantvision.se or fill out our form at Customised courses, and we'll get back to you with information on how we can assist you.

We look forward to helping you and your organization reach your Course goal.

Life sciences companies can accelerate the adoption of AI by assessing early on whether a planned AI use case is regulatory-compliant and suitable for its intended use, and then applying a risk-based process to the use cases that can move forward. 

Not all types of AI are suitable or permitted for all applications. This is particularly true in regulatory-critical processes, where the type of AI, its intended use, and the applicable regulations must be assessed before the solution is developed or implemented. 

For use cases that move forward, the organization can establish different risk levels, or “lanes.” AI use with low regulatory risk can be managed through simpler control processes, while use that affects, for example, GxP data, product quality, patient safety, or regulatory decisions may require more comprehensive risk assessment, documentation, validation, and control. 

In this way, compliance becomes part of how AI use cases are selected, designed, evaluated, and scaled from the outset, rather than a checkpoint after the solution has already been developed. 

A cross-functional approach that involves business operations, QA/RA, IT, information security, and AI expertise early on makes it possible to identify regulatory constraints and requirements before the organization invests time and resources in an AI use case that may not be usable as intended. 

Work on AI compliance and AI governance should begin before AI is introduced into regulated processes. A first step is to establish a structured process for identifying, assessing, and risk-classifying planned AI use cases based on intended use, regulatory impact, and potential risk. 

The organization needs to assess early on which processes AI will support, what information will be processed, which systems and vendors are involved, and what consequences an incorrect result could have. Based on this, it can determine which regulatory requirements and control measures need to be in Location before the solution is put into use. 

As part of the current state analysis, it is also important to identify any existing use of AI and ensure that it, too, is covered by the organization’s governance and risk management. 

The next step is to identify and prioritize gaps in areas such as AI governance, expertise, risk management, validation, cybersecurity, data integrity , and lifecycle management. 

A structured AI Readiness Assessment can provide the organization with a shared baseline and a risk-based roadmap for implementation. For more complex or regulatory-critical use cases, specialized expertise and an independent assessment can be valuable in interpreting the requirements and determining which controls need to be established. 

The goal is to create a framework in which new AI use cases can be assessed, approved, and managed before they are implemented, so that the organization can develop its use of AI without incorporating regulatory risks from the outset. 

Documentation for AI systems in GxP and life sciences should be risk-based and tailored to the system’s intended use, regulatory context, and potential impact on critical processes. 

Relevant documentation may include, for example, intended use, system and process descriptions, regulatory classification, risk assessment, data and data sources, supplier assessment, test and validation evidence, roles and responsibilities, human oversight, information security, change management, and monitoring. 

The goal is not to maximize documentation. The organization needs to be able to demonstrate why the AI system may be used, under what conditions, and what evidence shows that the risks are under control. The appropriate level of documentation is therefore a regulatory balancing act: too little creates a compliance risk, while unnecessarily extensive documentation can make the system difficult to manage as the AI solution evolves. 

AI agents can be used to automate aspects of, for example, information gathering, regulatory intelligence, documentation work, and quality processes; however, increased autonomy also entails new regulatory and operational risks. 

Unlike a traditional AI assistant, an AI agent can plan and execute multiple steps, use various systems and data sources, and, in some cases, initiate actions on its own. 

As the degree of autonomy increases, it is therefore necessary to assess, among other things, permissions, system access, audit trails, decision thresholds, escalation, human oversight, and the ability to stop and restore activities. 

For agent-based solutions, the risk assessment must therefore cover the entire workflow and not just the underlying AI model. Here, the combination of process understanding, compliance, and technical AI expertise becomes particularly important. 

Human oversight means that people have a defined and meaningful role in monitoring and controlling an AI system. Human-in-the-loop (HITL) is a common way to implement this, in which a qualified person actively reviews, evaluates, and, if necessary, corrects or halts an AI-generated result before it is used further. 

It is therefore not enough to simply add a formal approval step where a user clicks “Approve.” For “human-in-the-loop” to function as an effective risk control, the person must have the right expertise, access to relevant information, and the practical ability to detect and handle errors. 

The organization needs to define which tasks and decisions AI is permitted to support, when “human-in-the-loop” is required, which decisions must be made by humans, and what evidence needs to be reviewed before an AI-generated result is accepted. 

The level of human oversight must be tailored to the AI system’s intended use and risk. In regulated life science processes, it should therefore be designed and verified as an integral part of the control strategy—not as an administrative step that exists solely on paper. 

How AI from an external provider should be validated depends on what is being used, how the solution is structured, and what role the AI plays in the regulated process or product. Therefore, there is no general validation strategy for AI from third-party providers. 

For example, an organization does not typically validate a general-purpose AI service like Microsoft Copilot on its own. However, a tool or workflow built using Copilot may need to be validated based on its intended use and risk. 

In other cases, AI may be an integrated feature of a larger computerized system and, in turn, be based on models from additional third-party providers. In such cases, it is necessary to assess which part of the solution affects the regulated process and what evidence is required to demonstrate that the system is suitable for its intended use. 

If, instead, an external supplier develops AI that is to be incorporated into a medical device or IVD, the verification and validation requirements may be significantly more extensive and may also cover the underlying AI model and its development. 

Supplier assessment, documentation, testing, information security, change control, and access to relevant evidence must therefore be tailored to the solution’s architecture, intended use, risk, and applicable regulatory requirements. 

The key question, then, is not just who developed the AI, but what needs to be verified and validated to demonstrate that the solution in question is suitable and under control within its intended area of use. 

For generative AI and Large Language Models (LLM), hallucinations and incorrect results are a known and predictable risk. According to the EU’s current draft of GMP Annex 22, generative AI, LLMs, and other models with probabilistic outputs should not be used in critical GMP applications. Since the regulations are not yet final, the requirements may change before they take effect. 

For use outside of critical GMP applications, the risk of hallucinations and other errors must be assessed based on the specific use case. Key factors include the potential consequences of an incorrect result, the likelihood that the error will be detected, and how AI-generated information is used further in the process. 

Risk-mitigation measures may include, for example, human verification, verified information sources, requirements for citations, automated checks, and clear limitations on the types of information or decisions that the AI system is permitted to support. 

The risk assessment should therefore not focus solely on how often the model might produce an incorrect result, but rather on the overall risk: what happens when an error occurs, the likelihood of detecting it, and what controls are in place before the result can have any actual consequences. 

This provides a better basis for determining whether—and under what conditions—generative AI is suitable for the specific use case, as well as what technical and organizational controls are required. 

data integrity When using AI in GxP processes, this encompasses both the data used by the AI system and the information that the system generates, transforms, or summarizes. The requirements must therefore cover the entire information flow. 

The organization needs to understand data sources, access, transformations, storage, traceability, and how AI-generated information is used in subsequent processes. This must be linked to established GxP principles for the “ data integrity,” including ALCOA+. 

Special attention is required when AI-generated information becomes part of a GxP record or is used as the basis for a quality-related or regulatory decision. 

The issue of data integrity therefore often needs to be analyzed from multiple perspectives at the same time— QA, process, IT, data, and AI —since the risks do not necessarily lie in the model itself but rather in the entire data flow surrounding it. 

Changes to AI systems must be managed through established change control and risk-based lifecycle management, in which the impact of the change is assessed, documented, and, if necessary, leads to new testing, an updated risk assessment, or revalidation. 

It is important to distinguish between dynamic AI models that continuously learn and evolve and changes that occur within or around a static model. According to the EU’s current draft of GMP Annex 22, dynamic models that continuously learn after commissioning should not be used in critical GMP applications. Since Annex 22 is not yet final, the requirements may change before they take effect. 

Change management is also relevant for static AI models. New model versions, changes to configuration, data, integrations, the system environment, or updates from an external vendor can affect the system’s performance, intended use, or risk profile. 

The organization therefore needs to define which changes should be subject to change control, how their impact should be assessed, and when additional verification or revalidation is required. AI compliance does not end at go-live — monitoring relevant changes must be an integral part of the AI system’s entire lifecycle. 

AI-based medical devices and IVDs may be subject to both the MDR or IVDR and the EU AI Act. According to MDCG 2025-6, an AI system is classified as high-risk under the AI Act when it is a medical device or safety component and the product is simultaneously subject to third-party assessment by a notified body under the MDR or IVDR. 

In practice, this means, for example, that AI-based products in MDR Classes IIa, IIb, and III, as well as IVDR Classes B, C, and D, normally meet these requirements. Certain products in Class I and Class A may also be covered when their conformity assessment requires a notified body. 

For these products, the MDR or IVDR continues to apply to the medical device, while the relevant requirements of the AI Act must be met for the AI system. The requirements cover, among other things, risk management, quality management systems, technical documentation, data governance, transparency, human oversight, performance, and post-market monitoring. 

MDCG 2025-6 also clarifies that classification as “high-risk” under the AI Act does not change the product’s risk class under the MDR or IVDR. Instead, it is the product’s classification and the third-party assessment requirements under the MDR/IVDR that determine whether the AI system is subject to the high-risk requirements in Article 6(1) of the AI Act. 

For manufacturers, this means that the requirements need to be addressed in a coordinated manner within the product’s existing quality, risk management, and lifecycle processes, rather than as two separate regulatory tracks. 

Generative AI and Large Language Models (LLMs), such as ChatGPT and Copilot, can be used in GxP-regulated operations, but the scope of use is critical. According to the EU’s current draft of GMP Annex 22, generative AI, LLMs, and other models with probabilistic outputs should not be used in critical GMP applications. Since the regulations are not yet final, the requirements may change before they take effect. 

For use outside of critical GMP applications, the organization must conduct a risk-based assessment based on the specific use case. This involves, among other things, assessing what information may be processed, how data is handled by the supplier, how AI-generated output is used and verified, and what level of human oversight is required. 

The same AI service can therefore pose different risks depending on how and where it is used. Using generative AI for administrative or other non-critical tasks is different from using AI as part of a critical GMP process or as the basis for a quality-critical decision. 

It is therefore essential to classify the use case and its risks before implementing generative AI, and then determine which regulatory, technical, and organizational controls are required. At the same time, regulatory developments must be closely monitored when the use involves GMP. 

AI Governance in Life Sciences is the framework of roles, processes, responsibilities, and controls that governs how AI is selected, developed, used, monitored, and modified within the organization. 

An effective governance model needs to link operations, QA/RA, IT, information security, legal affairs, and management. Among other things, it should include the inventory and classification of AI systems, roles and responsibilities, risk assessment, approval of use cases, vendor evaluation, documentation, change management, and follow-up. 

At the same time, governance must be proportionate. An AI tool used for a low-risk administrative use case should not necessarily be subject to the same controls as AI that affects a GxP-critical process. 

Good AI governance is therefore not about maximum control, but about the right control for the right risk. 

An AI use case should be assessed based on the consequences of the AI system producing an incorrect, incomplete, or misleading result. The impact on patient safety, product quality, data integrity, regulatory decisions, or other GxP-critical processes are key factors in the assessment. 

The risk classification should also take into account the degree of automation, the data used, how the AI results are used subsequently, and the ability of humans to detect and correct an error. 

A structured classification of AI use cases makes it possible to apply different levels of control for different levels of risk. This helps the organization focus regulatory and technical resources where the risks are greatest, while control measures and documentation can be tailored proportionately for lower-risk AI uses. 

AI validation differs from traditional Computer System Validation (CSV) in that factors other than the system’s functional requirements may need to be assessed. Depending on the AI model and its area of application, factors such as data, model performance, robustness, transparency, human oversight, and changes over time may become key components of the validation and control strategy. 

At the same time, it is important to distinguish between different types of AI and their intended uses. For critical GMP applications, the EU’s current draft of GMP Annex 22 states that static AI/ML models with deterministic output may be used, while dynamic models and models with probabilistic output should not be used. This means that, for example, generative AI and Large Language Models (LLMs) are not suitable for critical GMP applications according to the current draft. 

The difference from traditional CSV, therefore, is not merely a matter of how AI should be validated, but also about first assessing whether the AI model in question is suitable and regulatory-compliant for use in its intended purpose. For those AI applications that can be used, validation must then be risk-based and cover relevant aspects of the model, data, performance, and the system’s use in the specific process. 

Since the GMP regulations for AI are still under development, the validation strategy must also take regulatory developments into account and be adapted once final requirements and guidance documents are published. 

Validation of AI Systems: AI systems used in or affecting GxP-regulated processes must be assessed based on their intended use, risk, and potential impact on, for example, patient safety, product quality, and data integrity. For AI used in critical GMP applications, specific requirements apply regarding control, documented evidence, and validation. 

At the same time, it is important to distinguish between different types of AI. The EU’s draft of the new GMP Annex 22 covers static AI/ML models with deterministic output, while dynamic models that continuously learn and models with probabilistic output should not be used in critical GMP applications. This also means that, according to the current draft, generative AI and Large Language Models (LLM) should not be used for such critical applications. 

For AI in GxP, the question is therefore not merely about how a system should be validated, but first whether the AI model is suitable and regulatory-compliant for its intended purpose. Subsequently, the validation strategy, evidence, acceptance criteria, and ongoing monitoring must be tailored to the use case and risk. 

Since the new Annex 22 is not yet final, organizations need to keep abreast of regulatory developments and continuously assess how upcoming requirements will affect planned and existing AI applications. 

AI in the life sciences may be subject to multiple regulatory requirements simultaneously, depending on the AI system’s intended use, risk level, and regulatory context. The EU AI Act is central, but other regulations—such as the MDR, IVDR, GMP/GxP, data protection, cybersecurity requirements, and established quality and risk management requirements—may also be relevant. 

The real challenge, therefore, rarely lies in a single set of regulations, but rather in understanding howdifferent requirements interact for that specific AI system and use case.

A risk-based regulatory assessment should therefore be conducted early on. It lays the foundation for determining which requirements apply, what documentation is needed, and what controls must be in place throughout the AI system’s lifecycle. In more complex applications, this assessment often requires regulatory, quality assurance, and technical AI expertise. 

Yes, absolutely. On the website, we share articles, webinars, and podcasts on topics such as AI in GMP, the AI Act, quality assurance, healthcare, and regulatory issues. Many organizations are currently in a phase where the focus is on understanding the opportunities, risks, and practical applications rather than “implementing AI everywhere.”

Please feel free to reach out if you’d like to discuss specific use cases, regulatory issues, or how other organizations are approaching AI in the life sciences today.

Needs often vary greatly from one organization to another. In some cases, support is needed with strategy and regulatory compliance; in others, with digital transformation, quality, or data management. Our consultants can provide both strategic and operational support, depending on where you are today.

We strongly believe in close collaboration and knowledge transfer to create solutions and work methods that are effective for the long term within our organization.

One of the biggest issues surrounding AI in regulated environments concerns reliability and control. We help organizations take a structured approach to areas such as data quality, model understanding, risk management, and documentation to create safer and more robust AI initiatives.

It's often just as much about work methods and governance as it is about the technology itself.

We work closely with our clients to understand their business processes, regulatory requirements, and technical constraints before recommending approaches or technologies. For some organizations, this involves creating a roadmap or governance structure for AI; for others, it involves exploring specific use cases in quality assurance, laboratory operations, or production.

Many people appreciate that we combine our experience in the life sciences with an understanding of technology, compliance, and change management.

We are seeing growing interest in AI in areas such as documentation, quality monitoring, CAPA processes, and regulatory information management. At the same time, AI must be used in a way that builds trust among operational, QA, and regulatory functions.

That is why we take a pragmatic, business-oriented approach, focusing on how AI can support people and processes rather than replace them.

AI in GMP often involves different requirements than traditional digitalization initiatives. Our consultants focus on quality, validation, governance, and regulatory understanding in environments where availability, data integrity , and compliance are central to operations.

These may include, for example, issues related to the validation of AI tools, the use of generative AI in quality processes, or how AI can be used without creating new regulatory risks.

The EU AI Act means that many organizations will need to adopt a more structured approach to areas such as risk management, model governance, data quality, and documentation related to AI. For operations within GMP, the Medtech , and regulated environments, it will be particularly important to demonstrate transparency, traceability, and control throughout the entire lifecycle of the AI solution.

We’d be happy to discuss how the regulatory framework is evolving and what that might mean for your business, based on your level of maturity and areas of application.

AI offers significant opportunities in areas such as documentation, analysis, quality assurance, and decision support—but in the life sciences, the technology must always operate within a regulatory and business-critical context.

It’s not just about what the model can do, but also about data quality, transparency, traceability, and how the solution is used in practice. We help organizations understand where AI can actually create value and how it can be done in a responsible and sustainable way.

It is the technical information that describes a facility; data and documents. Everything from flow charts to maintenance manuals. But also technical data like design pressure or flow.

Paper-based can be scanned in. Import Excel lists and thus make data more usable, accessible and searchable.

When all available information is gathered in one place, it becomes easy to search. This makes it quicker to find what you are looking for and there is less risk of finding conflicting information.

It is a system that can collect both data and documents, and create structures that correspond to the structures of the plant. An object, such as a pump, becomes a holder that can hold both technical data and all related documents.

Documentation is a subset of the facility information. Some people exclude drawings from documents, but these are included and are an important part. Other parts are technical data and "IT files" such as configuration files and firmware.

Yes. We’d be happy to tell you more about how we’ve helped companies in the industrial and process industries with plant design, retrofits, and technical projects in areas such as process engineering, automation, and infrastructure. Please feel free to contact us, and we’ll share relevant experiences and references.

We know that needs and circumstances can change quickly in industrial projects. That is why we work flexibly and closely with our clients to provide the right expertise at the right time—whether it involves specialist support, project management, or reinforcing existing teams.

Yes. We work on everything from minor modifications and improvement initiatives to larger investment and expansion projects. Our teams are tailored to the needs of the business and can provide support from the preliminary study and design phases through to implementation and commissioning.

We offer specialized expertise in several technical fields and can quickly assemble teams based on the business’s needs and the scope of the project. Our consultants work on strategic initiatives, project deliverables, and as support within the client’s existing organization.

We use modern tools and digital work methods to create structured documentation, models, and supporting materials that facilitate project implementation, management, and the future development of the facility.

We work closely with the business and the production organization to understand processes, constraints, and operational requirements before designing the solution. Our focus is on creating solutions that work effectively in real-world operations and can be implemented with minimal impact on production.

We work across disciplines—such as process engineering, automation, electrical engineering, instrumentation, and mechanical engineering—to ensure that the various parts of the plant function together as a whole. This leads to better coordination and more efficient project execution.

A well-thought-out facility design creates better workflows, greater safety, and more efficient use of resources throughout the entire operation. By combining an understanding of processes with technical design, businesses can reduce risks, simplify maintenance, and create better conditions for future development and expansion.

We work with several leading automation platforms and control systems in the industrial and process industries. Our consultants have experience in new development, migration, and further development of complex automation environments tailored to the needs of the business.

We work closely with your business to understand processes, production requirements, and technical dependencies before designing a solution. Our teams provide support throughout the entire process—from the preliminary study and design to implementation, testing, and further development of automation solutions. Get in touch—we’d be happy to tell you more or show you some case studies.

We take a proactive approach to redundancy, lifecycle management, risk analysis, and robust system design to ensure high availability and minimize the risk of downtime in mission-critical production environments.

We help organizations establish standardized work processes, architectures, and automation platforms to reduce complexity and create better conditions for management, further development, and scalability across multiple production facilities.

We work on integrating automation platforms with higher-level systems to create a seamless flow of information from production to business management. This enables better traceability, data-driven decisions, and more efficient processes throughout the organization.

We help businesses modernize and future-proof their automation environments through control system upgrades, migration of legacy solutions, and integration with modern digital platforms. Our focus is on long-term sustainability, availability, and minimizing the impact on production.

Automation creates the conditions for more stable processes, higher availability, and better resource utilization by reducing manual steps and standardizing production flows. It enables faster changeovers, better quality, and greater transparency in operations.

Yes, we have experience with various types of projects in the healthcare compliance and regulatory quality assurance, and some client case studies are featured on our website. At our first meeting, we’d be happy to tell you more about similar projects, our experiences, and how we’ve helped other organizations establish sustainable work practices and ensure compliance in practice. 

Yes, we regularly assist organizations that need to strengthen their teams with expertise in healthcare compliance, quality, and regulatory matters. Whether the need involves specialist support, change management, or long-term initiatives, our focus is on quickly finding the right solution and the right expertise based on the organization’s needs. 

We have extensive experience in compliance, quality, and regulatory work in the life sciences, laboratory operations, and healthcare. Our consultants have worked on everything from regulatory implementation and quality assurance to change management and operational compliance in complex environments. 

Yes, we help organizations prepare for inspections and audits and ensure that regulatory requirements are properly implemented and documented. For example, our consultants provide support with structuring, interpreting requirements, conducting gap analyses, and implementing improvements related to NMI processes and regulatory compliance. 

What sets us apart is our combination of regulatory expertise and an understanding of how healthcare and laboratory operations actually work in practice. Our consultants have experience working closely with these operations and focus on solutions that enhance quality and patient safety while remaining realistic and sustainable over time. 

We work closely with our clients, focusing on creating sustainable work practices that work in everyday situations. Our consultants help organizations interpret requirements, establish structures, and implement processes that support both compliance, quality, and operational activities without creating unnecessary administrative burdens. 

We work with regulatory issues related to, among other things, the MDR, the IVDR, and related standards and quality requirements in healthcare and laboratory settings. Our consultants have experience supporting organizations in complex regulatory environments where quality, patient safety, and effective processes are central to operations. 

We help healthcare organizations translate regulatory requirements into effective, practical workflows. Our consultants provide both strategic and operational support in areas such as the MDR, IVDR, quality management, in-house manufacturing, change management, and the implementation of regulatory requirements within the organization. 

Yes. We’d be happy to tell you more about how we’ve helped companies in the manufacturing industry create better decision-making tools, increase transparency in production, and use data to streamline processes and improve business results. Please feel free to contact us, and we’ll share relevant experiences and examples from past projects.

We help businesses integrate Data Intelligence solutions with existing OT, MES, ERP, and cloud platforms to create a cohesive data flow and avoid information silos.

We work closely with the business to understand processes, information flows, and business needs before designing a solution. Our teams provide support throughout the entire journey—from strategy and architecture to implementation, visualization, and the further development of data platforms and analytics solutions.

Real-time data makes it possible to identify deviations more quickly, monitor KPIs, and make decisions based on the current production status. This creates better conditions for proactive management and continuous improvement in the business.

Data quality is a central part of our Data Intelligence work. We focus on data modeling, structuring, and quality assurance to ensure that the right data is used in the right context and that the information is traceable and reliable.

We help businesses integrate data from sources such as SCADA, MES, ERP, historical databases, and production equipment to create a unified flow of information. The goal is to make production data accessible and usable throughout the entire organization.

By collecting, organizing, and visualizing data from multiple systems and production sources, we create better conditions for data-driven decisions. This enables faster analysis, greater transparency, and better control over production, quality, and processes.

Yes, absolutely. We have experience working with organizations in sectors such as energy, the process industry, pharmaceuticals, and manufacturing, where we have helped customers improve availability, modernize OT environments, and create more data-driven approaches to operations and maintenance.

Please feel free to contact us if you’d like to discuss similar challenges or get a deeper understanding of how we work in practice.

Operational and facility environments are becoming increasingly connected, while demands for availability and security are rising. We help organizations strengthen their resilience and cybersecurity through measures such as segmentation, OT infrastructure, risk analysis, and secure integration solutions—always taking into account production requirements for stable operations.

As operational data, asset information, and production-related data become more accessible, better conditions are created for both operational and strategic decisions. This may involve, for example, identifying bottlenecks, analyzing availability, prioritizing maintenance efforts, or creating a better basis for decision-making regarding investments and modernization.

We know that the need for specialized expertise often varies depending on the project phase, investments, and business-critical initiatives. That is why we take a flexible approach and can provide support through both individual specialist roles and cross-functional teams in areas such as OT, maintenance, automation, data analysis, and industrial digitalization.

Many clients appreciate that we can combine strategic insight with an operational presence within their business.

Our consultants work closely with business operations, production, and the engineering organization to ensure that solutions work in practice—not just technically. We combine specialized expertise in OT, automation, integration, data management, and plant design, depending on the project’s needs and complexity.

This enables us to provide support both for major transformation initiatives and for operational improvement efforts.

We help businesses use real-time data, historical data, and production-related information to make better-informed decisions regarding maintenance, lifecycle management, and availability.

For many organizations, this involves shifting from reactive maintenance to more predictive and risk-based approaches, where operational disruptions can be identified earlier and resources can be used more efficiently.

Many of our customers operate in complex environments where legacy infrastructure and new digital initiatives need to coexist for an extended period of time. We help organizations gradually modernize their OT, maintenance, and information environments without compromising operational reliability or availability.

This can range from integration and migration to the structuring of facility information, the modernization of OT infrastructure, or the implementation of data-driven work methods in operations and maintenance.

Today, many organizations have critical information scattered across maintenance systems, document management systems, OT environments, and manual workflows. We help customers create a more cohesive information model in which operational data, technical documentation, asset information, and maintenance processes are linked in a more structured way.

This makes it easier to take a data-driven approach throughout the facility’s entire lifecycle—from investment and change projects to day-to-day operations and management.

Yes. We’d be happy to tell you more about how we’ve helped companies in the industrial and process industries improve availability, reduce operational disruptions, and create more robust production environments through integration, automation, and data-driven solutions. Please feel free to contact us, and we’ll share relevant experiences and references.

Yes. We serve both as a long-term partner and as a source of support during urgent challenges or change initiatives. Our teams can quickly provide the right expertise to enhance operational reliability, stability, and the further development of production environments.

We offer specialized expertise in areas such as automation, OT, integration, infrastructure, and industrial digitalization. Our consultants can provide support for strategic initiatives, projects, and day-to-day operations, flexibly tailored to the organization’s needs and available resources.

We work closely with the business to understand processes, technical dependencies, and production-critical systems before designing the solution. Our teams provide support throughout the entire process—from analysis and strategy to implementation, monitoring, and further development of reliable solutions.

We utilize risk analysis, redundancy, and robust system design to minimize vulnerabilities and ensure high availability in mission-critical environments. Our solutions are tailored to meet each organization’s requirements for operational reliability and continuity.

Real-time data makes it possible to continuously monitor production environments and more quickly identify deviations, changes in performance, and risks. This creates better conditions for proactive maintenance and faster response to disruptions.

By taking a proactive approach to monitoring, analyzing, and optimizing production environments, organizations can identify risks and anomalies before they lead to downtime. This results in improved availability, more stable processes, and a reduced impact on production.

We take a pragmatic, business-oriented approach, focusing on creating QMS structures that support operations in practice. By combining regulatory expertise with experience from operational environments, we help organizations balance compliance, efficiency, and flexibility over time. Please feel free to contact us to discuss how we can support your organization in the areas of quality management and compliance. 

Yes, we offer support for internal and external audits as well as regulatory inspections through, for example, gap analyses, remediation, documentation reviews, and quality assurance of processes and QMS structures. We help organizations create the conditions for sustainable and audit-ready work practices. 

We support organizations in ensuring data integrity, version control, and document management throughout the quality management system. Our consultants have experience with both digital and business-oriented quality processes where traceability, control, and regulatory compliance are key requirements. 

Yes, we help organizations establish and improve processes for CAPA, deviations, and change control , and risk management. The focus is on creating effective and traceable work methods that strengthen both compliance and the organization’s culture of quality. 

We work with quality management systems, including ISO 13485, ISO 9001, ISO 15189, GMP, MDR, and IVDR. Our consultants have experience translating regulatory requirements into effective processes and quality structures in the fields of Medtech, laboratory operations, and life sciences. 

We help organizations establish, adapt, and further develop quality management systems based on regulatory requirements, business objectives, and organizational maturity. Our consultants provide specialized expertise in process design, governing documentation, governance , and implementation in complex and regulated environments. 

Needs vary depending on the business, regulatory requirements, and internal resources. We help you identify the right expertise and the right level of support, whether you need a specialist consultant, project management, or a long-term partnership in healthcare compliance. Please feel free to contact us, and we’ll be happy to tell you more about how we can help your specific business. 

Yes, we offer support in technical documentation, risk management in accordance with ISO 14971, and documentation processes related to medical devices. We help you ensure that your documentation meets the required quality standards and is ready for an audit or review. 

We take a hands-on approach and focus on solutions that work in practice. Our consultants help implement new regulatory requirements without disrupting day-to-day operations, while strengthening internal work methods, processes, and expertise. 

Absolutely. Many organizations face challenges related to a lack of resources or a need for specialized expertise in regulatory matters. We can provide support in the form of both strategic advice and operational assistance, tailored to the organization’s needs and circumstances. 

We offer specialized expertise in regulatory requirements, quality management, risk management, technical documentation, and project management in the fields of Medtech and healthcare. Our consultants have extensive experience working in industry, laboratory operations, and healthcare. 

Yes, we help organizations develop, implement, and improve quality management systems in accordance with standards such as ISO 13485, ISO 9001, and ISO 15189. We can provide support both for individual projects and as a long-term partner in quality and compliance. 

We offer support throughout the entire process, from requirements analysis and gap analyses to implementation, documentation, and quality assurance in accordance with the MDR and IVDR. Our consultants help both private and public organizations establish structured work processes that function effectively in day-to-day operations and are ready for audit. 

Healthcare Compliance involves ensuring that medical devices, processes, and work methods meet regulatory requirements and quality standards, such as the MDR, IVDR, and ISO 13485. We help healthcare organizations put these requirements into practice through hands-on support, documentation, and quality assurance. 

Yes. We’d be happy to tell you more about how we’ve helped companies in the industrial and process industries create better information flows, reduce manual processes, and integrate OT and IT environments using modern integration solutions. Please feel free to contact us, and we’ll share relevant experiences and references.

Security and data integrity are central components of our integration projects. We work with secure communication solutions, access management, and structured data management to ensure stable and reliable information flows between systems and platforms.

We work closely with the business to understand processes, system dependencies, and information flows before designing the solution. Our teams provide support throughout the entire process—from the preliminary study and architecture to implementation, testing, and further development of integration platforms and data flows.

We help businesses collect, organize, and distribute real-time production data to enable faster decision-making, better monitoring, and more efficient management of business-critical processes.

We work with established integration patterns, standardized interfaces, and scalable architecture to create solutions that can evolve over time and adapt to changing business requirements and system landscapes.

We specialize in integration between, for example, MES, ERP, SCADA, historical databases, automation platforms, and cloud services. Our solutions are tailored to the organization’s technical environment, architecture, and integration needs.

Integrating systems and data flows between OT and IT creates greater transparency, faster information transfer, and higher data quality. This provides businesses with better conditions for data-driven decisions and more efficient processes throughout the entire production chain.

Yes. We’d be happy to tell you more about how we’ve helped manufacturing companies improve their quality processes, enhance traceability, and gain better control over production and quality data through digital solutions and integrations. Please feel free to contact us, and we’ll share relevant case studies and references.

We help organizations create structured and digitized processes for nonconformance management, CAPA, and quality monitoring. Our focus is on traceability, efficient management, and creating better conditions for proactive quality work.

Yes. We help businesses integrate quality processes and quality data with systems such as MES, ERP, SCADA, and production systems to create a cohesive flow of information and reduce manual tasks.

We work closely with the business to understand processes, quality requirements, and organizational needs before designing a solution. Our teams provide support throughout the entire journey—from analysis and strategy to implementation, integration, and the ongoing development of quality solutions and work methods.

By collecting and analyzing quality data in real time, organizations can more quickly identify trends, root causes, and areas for improvement. This provides a better basis for decision-making and strengthens efforts toward continuous improvement and process optimization.

We provide solutions that ensure quality data is accurate, accessible, and traceable throughout the entire production chain. This includes system integration, structured data management, and support for regulatory and business-critical requirements.

We help businesses digitalize quality processes by integrating production systems, quality data, and analytics tools. The goal is to improve traceability, accelerate deviation handling, and foster a more data-driven approach to quality management across the entire organization.

A structured quality assurance process provides better control over processes, data, and production outcomes. By identifying deviations early and working proactively with quality data, businesses can reduce variability, improve delivery accuracy, and create more stable production flows.

Yes, we have experience with a wide range of projects in quality assurance and regulatory quality work, and several client case studies are featured on our website. At our first meeting, we’d be happy to tell you more about similar projects, our experiences, and how we’ve helped other organizations develop sustainable quality structures and strengthen their compliance over time. 

Yes, we regularly assist organizations that need to strengthen their teams in quality assurance, QA, and QMS—both for specific projects and as long-term support. Whether the need is for specialized expertise, interim roles or support with change management, our focus is on quickly finding the right solution and the right consultant profile based on the organization’s needs. 

We have extensive experience with quality assurance in regulated industries such as life sciences, Medtech, laboratory operations, and industry. Our consultants have worked on everything from establishing quality management systems and QA processes to risk management and audits , and regulatory compliance in complex environments. 

Yes, we support organizations in preparation for internal and external audits as well as regulatory inspections through, for example, gap analyses, documentation reviews, CAPA activities, and quality assurance of processes and QMS structures. The goal is to ensure confidence and audit readiness throughout the entire process. 

What sets us apart is our combination of regulatory expertise, business acumen, and a pragmatic approach. Our consultants have experience with quality assurance in real-world operations and understand the interplay between compliance, quality, and operational needs. We focus on solutions that work over the long term—not just in preparation for the next audit. 

We work closely with our business operations and integrate quality assurance into our daily work—from projects and product development to production and after-sales service. Our focus is on creating structures that support our operations, reduce risks, and function effectively over the long term without creating unnecessary complexity. 

We work with quality management systems in regulated industries and have experience in areas such as GxP, MDR, IVDR, ISO standards, CFR, and MDSAP. Our consultants help organizations translate regulatory requirements into sustainable work practices, processes, and quality structures. 

We help organizations build, develop, and refine quality assurance and quality management systems that work in practice and meet regulatory requirements. Our consultants work at both the strategic and operational levels in areas such as QA, QMS/eQMS, audits, risk management, and quality processes throughout the entire product lifecycle. 

Laboratory automation reduces manual tasks and creates faster, safer, and more standardized processes. Through automated workflows and smart system integration, laboratories can improve productivity, quality, and data accessibility.

We work with laboratories in sectors such as pharma, biotech, medtech, foodtech, and manufacturing. Our consultants have experience with both research-oriented laboratories and regulatory-compliant quality and production environments.

Yes. Many laboratories currently use older systems and manual processes. We help modernize laboratory environments through digitization, integration, and the updating of systems and workflows to improve efficiency and ensure future readiness.

We have experience with regulated laboratory environments and assist organizations with validation, data integrity , and compliance with standards such as GMP and GxP. Our solutions are designed to support traceability, quality, and the secure handling of laboratory data. Please contact us—we’d be happy to tell you more.

Yes. We help laboratories integrate instruments, LIMS, ERP, MES, and other business-critical systems to create automated and seamless data flows throughout the organization.

Yes. Thermo Scientific SampleManager LIMS is one of the market’s leading LIMS platforms and is used by many laboratories in the life sciences, pharmaceutical, and industrial sectors. We assist with the implementation, development, integration, validation, and further development of SampleManager based on your organization’s needs.

A LIMS streamlines laboratory processes through automated sample handling, digital documentation, and better control over data flows. It reduces manual work, improves data quality, and makes it easier to comply with regulatory requirements.

Laboratory Information Management System (LIMS) is a system for managing laboratory data, samples, workflows, and documentation. A LIMS helps laboratories improve traceability, quality, and efficiency by collecting and organizing data in a single system.

When it comes to the digitization of business functions in manufacturing companies, the main focus is on these four areas: quality, production, inventory and maintenance.

Digging deeper into the production perspective, these are: Production planning (planning and scheduling), Material flows and manufacturing flows (routing), Resource management (personnel, authorizations, etc.), equipment and machine status, product information, release, quality management (quality checks, SPC, yield, rejects, rework), production follow-up (stop motion analysis, equipment availability, OEE), data collection (machine hook-ups, manual input, sensor, IIOT, etc.), inventory (warehouse, truck transportation, material buffers, inventory, QR and barcode counting), automation and control systems.

Some key technologies include:

• Production planning and scheduling from customer order to delivery (meeting delivery dates, managing changes in production based on material and machine availability and actual outcome per operation).
• MES (Manufacturing Execution Systems): For real-time monitoring and control of production processes.
• IIoT (Industrial Internet of Things): to connect machines and collect data.
• Big Data and AI: To collect and analyze large amounts of data and improve production processes and decision-making (e.g. quality checks with AI or analysis of large amounts of process data)
• Automation and Robotics: To automate manual processes.
• Digital Twins: To quickly create digital copies of the production process and see the impact of changes digitally before they are introduced in reality.

In order to have traceability throughout production and the possibility to act and coordinate production in real time, the following data is in focus:

• Production data: Data on production speed, cycle times, and machine performance.
• Quality data: Data on defects, recalls and quality checks.
• Maintenance data: Data on machine maintenance and downtime.
• Sales data: Data on orders, sales trends and customer feedback.

OEE, which stands for Overall Equipment Effectiveness, is a key performance indicator used to measure and improve the efficiency of manufacturing processes. In Swedish, the term TAK is used, which stands for Availability, Plant Utilization and Quality. OEE takes into account different types of production losses and divides them into three categories:

• Availability: Measures losses that occur due to downtime.
• Performance (Plant Utilization): Measures losses due to machines or processes running slower than the maximum speed.
• Quality: Measures losses of products that do not meet quality standards.

By combining these three factors, OEE provides an overall picture of how efficiently a manufacturing process is working. A high OEE value indicates an efficient and optimized production with minimal losses.

A Manufacturing Execution System (MES) is a system that monitors, controls and collects information about production processes in real time. MES systems help ensure efficiency and quality by integrating and optimizing both processes and information from all areas of production. This type of system becomes the heart of production, helping to coordinate and optimize production activities to improve quality, efficiency and profitability.

• Production planning and scheduling
• Resource and material management
• Production monitoring and control
• Quality management
• Traceability
• Work order management
• Operator management and digital work instructions
• Performance analysis and production monitoring
• Reports and dashboards with real-time production data
• Integration with ERP and peripheral systems

A digital platform for production is an important piece of the puzzle and a tool on the journey towards Industry 4.0 and 5.0 for manufacturing companies.

MES systems are at the heart of production and are central to enabling Industry 4.0 by integrating and automating production processes. As a tool for digital transformation towards the smart factory, this type of system helps to connect machines, people and peripheral systems. By collecting and analyzing real-time data, they improve the productivity, quality and flexibility of manufacturing processes. They also enable predictive maintenance and resource optimization, reducing downtime and increasing efficiency.

For companies aiming for Industry 5.0, MES systems play an important role by supporting and coordinating human-machine collaboration. They also facilitate sustainability monitoring and reporting under the CSRD directive, for example, and help companies to monitor their use of resources and reduce their energy consumption and environmental impact. Digital production platforms and MES/MOM solutions integrate automation with human expertise, making companies better equipped to innovate, focus on customers, and address new challenges and rapid changes towards smarter and more sustainable production.

Needs vary depending on the product, market, internal resources, and timeline. We’re happy to help conduct an initial review and identify the right level of support, whether it’s for a specific project, a new market, or a long-term partnership. Please feel free to contact us, and we’ll tell you more.

What sets us apart is our combination of global regulatory experience and a practical, business-oriented approach. We focus on solutions that work in practice and support both compliance and business objectives.

Market Access doesn’t end with approval. We also provide support with registration follow-up, renewals, change control, and impact assessments across multiple markets. This ensures ongoing compliance and reduces the risk of interruptions in market access.

Absolutely. Many organizations lack the ability to build up full in-house expertise for all markets. We can step in as an extension of their regulatory team and take responsibility for all or part of the market access work, tailored to the organization’s needs and level of maturity.

A clear strategy, the right priorities, and high-quality applications reduce the risk of requests for additional information and delays. We take a structured, risk-based approach to ensure predictability in the process and efficient management of interactions with regulatory authorities.

Yes, we provide both strategic and operational support. This may involve developing an overall market access strategy, prioritizing markets, and selecting a regulatory pathway, as well as hands-on work with documentation, submissions, regulatory matters, and follow-up.

We have experience with market access in several global markets, including the EU, the U.S., China, Japan, Brazil, Canada, Australia, and the Middle East. Our work includes, among other things, MDR, IVDR, FDA processes, NMPA, PMDA, and other national regulations depending on the market and product.

Market Access is about ensuring that a medical device can be launched and continue to be sold in selected markets in accordance with applicable regulatory requirements. This includes, among other things, regulatory strategy, submissions, engagement with regulatory authorities, and ongoing compliance throughout the product’s lifecycle.

Yes, absolutely. We have experience working with companies in the pharmaceutical, energy, process, and manufacturing industries, among others, where we have helped clients modernize their OT environments, strengthen cybersecurity, and improve integration between production, data, and business systems.

Please feel free to contact us if you’d like to discuss similar challenges or get a deeper understanding of how we work in practice.

We help customers create scalable and sustainable OT environments where new digital initiatives can be built upon over time. This may involve, for example, standardization, segmentation, integration between OT and IT, or the establishment of modern data and communications structures that support Industry 4.0 and smart manufacturing.

OT needs often vary depending on the business, project phase, and technical maturity. That is why we take a flexible approach and can provide support through both specialist roles and cross-functional teams in areas such as OT architecture, cybersecurity, automation, integration, and data management.

Many customers appreciate that we can combine in-depth technical expertise with an understanding of the production environment’s requirements for stable operation and high availability.

As OT data becomes more accessible and contextualized, it creates better conditions for data-driven decisions in production, maintenance, and the supply chain. We help businesses collect, structure, and visualize data from sources such as PLCs, SCADA, historical databases, and MES systems to create greater transparency and faster decision-making processes.

We combine specialized expertise in automation, OT infrastructure, integration, cybersecurity, and industrial digitalization to create solutions that work both technically and operationally. Our consultants work closely with business operations and production teams to understand the actual challenges in the operational environment—not just the system architecture on paper.

This enables us to provide support both for strategic transformation initiatives and for more operational improvement efforts.

OT environments have different requirements and conditions than traditional IT, especially in business-critical production environments where availability is crucial. We help organizations strengthen their cybersecurity through measures such as segmentation, risk analyses, OT monitoring, and secure integration solutions.

We also work with partners such as Nozomi Networks, Truesec and Xertified to create modern and robust OT environments tailored to the industry’s requirements.

In modern production environments, IT and OT need to work together more closely than ever to enable better information flows, data-driven decisions, and increased transparency throughout the entire organization. At the same time, the requirements differ between the two environments: OT often places high demands on availability and stable operation, while IT focuses more on flexibility, scalability, and information security. We help organizations create secure and sustainable integration solutions where communication between IT and OT functions effectively without compromising the requirements and conditions of each environment.

For many customers, it’s not just about technology, but also about governance, risk management, and creating a sustainable architecture over time.

Many organizations today face the challenge of having older OT environments coexist with new requirements for connectivity, data sharing, and cybersecurity. We help customers modernize their OT infrastructure and production-related systems in a phased approach—with a focus on robustness, availability, and long-term manageability.

It often comes down to striking a balance between stable operations, secure integration, and future digitalization initiatives without disrupting production more than necessary.

Yes, we often help companies that need to strengthen their teams in QA, quality assurance, or compliance , both for specific projects and as long-term support. Our consultants have experience in regulated industries and can quickly familiarize themselves with both processes and regulatory requirements. Please feel free to contact us, and we’ll tell you more about the expertise we currently have available and how we can support your business. 

We work closely with your business and tailor our services to your organization’s structure, maturity, and needs. Our consultants combine regulatory expertise with operational experience to create solutions that work in practice over the long term. Please feel free to contact us to discuss how we can support you in operational quality assurance and QA. 

Yes, we offer support for internal and external audits as well as regulatory inspections through, for example, gap analyses, process reviews, documentation support, and quality assurance of existing work practices. Our consultants help organizations strengthen their audit readiness and reduce regulatory risks. 

Effective QA work not only contributes to compliance but also to more stable processes, reduced risk, and increased efficiency. We help organizations establish sustainable quality structures that support business objectives, product quality, and long-term growth. 

Absolutely. Many organizations need temporary or long-term support in quality assurance, for example, during change initiatives, audits, or in response to increased regulatory requirements. We offer experienced consultants in QA, quality management, and compliance tailored to your organization’s needs. Get in touch, and we’d be happy to tell you more.

We focus on creating quality assurance that supports our operations rather than of creating unnecessary administrative burdens. Through a risk-based and business-oriented approach, we help organizations balance regulatory requirements with operational efficiency and usability. 

Yes, we support organizations in developing QA processes and work methods that enhance quality, traceability, and efficiency. This may involve, for example, deviations, CAPA, change control, risk management, or processes related to auditing and quality assurance. 

We specialize in quality assurance for regulated industries and have experience with GMP, ISO standards, MDR, and IVDR, among others. Our consultants help organizations interpret and implement regulatory requirements in a pragmatic and sustainable manner. 

We help organizations establish, develop, and streamline QA functions that ensure compliance, quality, and effective working practices in practice. Our consultants work closely with business operations on processes, quality structures, and quality assurance throughout the entire product lifecycle. 

We work with several leading platforms and technology providers in the fields of industrial digitalization, OT, cybersecurity, and automation. Our partners include, for example, Nozomi Networks, Truesec and Xertified, along with other established players in the industrial and cybersecurity sectors. Through our partnerships and specialized expertise, we help businesses implement, integrate, and further develop solutions tailored to both technical and operational needs. Feel free to reach out, and we’ll be happy to tell you more about our partnerships and experience in various technology areas.

Yes. We work both on specific projects and as a long-term partner in the management and further development of OT environments. Our teams can quickly provide support in the event of changes, resource needs, or modernization initiatives in production-critical environments.

We offer specialized expertise in OT infrastructure, networks, cybersecurity, automation, and industrial digitalization. Our consultants can provide support for strategic initiatives, projects, and day-to-day operations—flexibly tailored to your organization’s needs and resources.

We work closely with the business to understand the production environment, system dependencies, and business-critical requirements before designing the solution. Our teams provide support throughout the entire process—from analysis and architecture to implementation, migration, and further development of OT environments.

We help businesses modernize and future-proof legacy infrastructure through upgrades, migrations, and integration with modern platforms and production systems. The goal is to create sustainable solutions with minimal impact on production.

We work with segmentation, secure communication, access management, and risk-based design to strengthen the security of OT infrastructure. Our solutions are tailored to meet the organization’s requirements for availability, security, and regulatory compliance.

We help organizations create secure and scalable solutions where OT and IT environments can interact effectively. Our focus is on robust communication, data availability, and an architecture that supports both production and business needs.

We work with several leading platforms and technology providers in the fields of industrial digitalization, OT, cybersecurity, and automation. Our partners include, for example, Nozomi Networks, Truesec and Xertified, along with other established players in the industrial and cybersecurity sectors. Through our partnerships and specialized expertise, we help businesses implement, integrate, and further develop solutions tailored to both technical and operational needs. Feel free to reach out, and we’ll be happy to tell you more about our partnerships and experience in various technology areas.

IT security focuses on information systems, while OT security is about protecting the operational technologies that control physical processes - for example in manufacturing, energy and transportation. OT systems are often older, more difficult to access and integrated with physical infrastructure, requiring specific methods and tools to secure them.

Many OT environments are built on legacy systems that lack basic protection. At the same time, more industrial systems are being connected to the internet and cloud services, increasing exposure to attacks. In addition, clear security processes and business continuity plans are often lacking.

We offer support throughout the entire process - from GAP analysis and risk assessment to safeguards implementation and follow-up. Our approach is based on international standards and we tailor measures to strengthen both compliance and practical security.

We offer targeted cybersecurity training for different audiences, from operational staff to management. The focus is on creating an understanding of the threat landscape, building a culture of security and providing concrete tools for responding to incidents.

Cloud computing can streamline OT operations but also brings new security challenges. We help you ensure that the right protection is in place on Location, both technically (such as segmentation and encryption) and organizationally (procedures, responsibilities and monitoring).

The timeframe depends on the scope of the assignment, but we are used to mobilizing resources quickly and can often start an initial analysis or feasibility study within a couple of weeks.

Yes, absolutely. We’d be happy to tell you more about how we’ve helped companies in the manufacturing industry improve delivery accuracy, achieve a better balance between capacity and demand, and develop more data-driven planning processes.

Please feel free to contact us, and we’ll share relevant experiences, examples, and approaches based on the types of challenges you’re facing today.

We know that successful planning is not just about technology, but also about people, work methods, and buy-in within the organization. That is why we place great emphasis on ensuring that our solutions work in everyday use and create real value for users.

Through close dialogue and a pragmatic approach, we help organizations bring about changes that stand the test of time.

The situation varies greatly from one business to another, which is why we take a flexible approach based on the client's needs. Sometimes this involves a specialist consultant for a specific project; other times, it involves an entire team providing support during a longer-term transformation.

We can provide expertise in areas such as APS, integration architecture, supply chain, data analysis, and industrial digitalization—both strategically and operationally—depending on where the need arises.

We believe in close collaboration between business, production, and technology. That is why our consultants work closely with both decision-makers and operational teams throughout the entire change journey—from strategy and analysis to implementation and further development.

Many of our customers appreciate the combination of technical expertise and an understanding of how change actually works in practice.

For planning to create real value, it must be closely linked to production. We therefore focus heavily on integration between APS, ERP, MES, and production-related systems to create a more cohesive and data-driven decision-making framework.

This makes it possible to adapt planning more quickly as circumstances change, something that is becoming increasingly important in today's industrial environments.

We help businesses implement and further develop APS solutions where planning is based on actual production conditions—not static Excel models or manual processes.

Our consultants have experience with complex production environments where factors such as capacity, material flows, setup times, and delivery requirements must be taken into account. Please feel free to contact us if you’d like to discuss how a modern APS solution could work for your specific business.

We work closely with our customers to create planning processes that can handle changes in demand, supply disruptions, and capacity challenges without losing control or compromising our ability to deliver.

It often involves creating greater transparency, smarter information flows, and a clearer link between planning and production. Every business is different, which is why we always tailor our approach and solutions to the customer’s needs and goals.

AI and data-driven analytics create entirely new opportunities to take a more proactive approach to planning, forecasting, and capacity management. By combining real-time data, historical data, and smart analytics, businesses can identify deviations more quickly, reduce manual decision-making, and create more resilient supply chain flows.

We’d be happy to help you discuss which options are most relevant based on your production, operations, and level of maturity.

Yes. We’d be happy to tell you more about how we’ve helped companies in the industrial and process sectors achieve greater transparency, more efficient monitoring, and data-driven production through solutions for performance and real-time data. Please feel free to contact us, and we’ll share relevant case studies and references.

We work with quality assurance, structuring, and validation of data flows to ensure that the right information is used in the right context. This provides a reliable basis for decision-making and creates better conditions for analysis and follow-up.

We work closely with the business to understand processes, information needs, and technical dependencies before designing the solution. Our teams provide support throughout the entire journey—from analysis and architecture to implementation, visualization, and further development of data-driven solutions.

By continuously monitoring production data, businesses can more quickly identify deviations, causes of downtime, and inefficiencies in their processes. This creates better conditions for data-driven optimization and continuous improvement.

We work on integrating production-related systems with business platforms to ensure that real-time data can be used for everything from operational monitoring to analysis, reporting, and decision support at the business level.

We help businesses collect and organize data from sources such as SCADA, PLCs, MES, historical databases, and production equipment to create accessible and actionable information flows throughout the organization.

Real-time data improves transparency in production and makes it possible to track KPIs, identify deviations, and make decisions based on the current operational status. This gives businesses a better foundation for working proactively to improve efficiency, quality, and availability.

Yes. We’d be happy to tell you more about how we’ve helped companies in the manufacturing and process industries streamline production flows, improve quality outcomes, and create better decision-making support through data-driven process optimization. Please feel free to contact us, and we’ll share relevant case studies and references.

Real-time data makes it possible to identify deviations more quickly, monitor production results, and make decisions based on current operational status. This creates better conditions for proactive management and optimization of production in real time.

We work closely with the business to understand its processes, goals, and challenges before designing a solution. Our teams provide support throughout the entire journey—from analysis and strategy to implementation, visualization, and the further development of optimization initiatives and digital solutions.

We help businesses integrate data from systems such as MES, SCADA, ERP, and automation platforms to create greater transparency and enable optimization based on up-to-date and reliable production data.

We analyze production flows, capacity, quality data, and real-time information to identify bottlenecks and opportunities for improvement in the processes. Our focus is on creating long-term, sustainable, and measurable improvements.

We help businesses collect, analyze, and visualize production data to create a better basis for decision-making and identify areas for improvement. By combining process expertise with digital solutions, we lay the groundwork for continuous improvement and proactive management.

Process optimization helps businesses identify bottlenecks, reduce variability, and improve resource utilization through data-driven analysis and improved workflows. The goal is to create more stable processes, higher productivity, and better quality throughout the entire production process.

Yes. We’d be happy to tell you more about how we’ve helped companies in the manufacturing industry streamline their S&OP processes, improve delivery accuracy, and achieve a better balance between capacity, materials, and demand through modern planning solutions. Please feel free to contact us, and we’ll share relevant case studies and references.

Among other things, we work with Siemens Opcenter APS and TrakSYS to create flexible, data-driven planning solutions tailored to the needs of the business and the production environment.

We work closely with the business to understand processes, planning logic, and organizational dependencies before designing the solution. Our teams provide support throughout the entire journey—from analysis and strategy to implementation, integration, and further development of planning processes and APS platforms.

Production planning needs to function as part of a cohesive flow of information. We integrate APS and planning solutions with ERP, MES, and production systems to ensure that planning is based on accurate and up-to-date operational data.

We help businesses establish data-driven planning processes that allow them to quickly simulate and analyze various scenarios. This makes it possible to evaluate the impact of, for example, changes in capacity, material shortages, or shifts in demand before decisions are made.

Modern planning solutions can handle multiple production strategies in parallel and balance forecast-driven production with customer-order-driven flows. This creates greater flexibility and makes it possible to optimize both inventory levels and delivery accuracy.

We work with APS solutions where planning is based on actual capacity, available resources, material flows, and production constraints. This makes it possible to create realistic plans that can be dynamically adjusted in response to changes in production.

Production planning focuses on balancing demand, capacity, and material availability at the tactical and strategic levels, while scheduling involves the detailed operational planning of resources and the production sequence. Together, they create the conditions for stable and optimized production.

Yes, we have consultants with experience in project management in areas such as life life sciences, laboratory operations, production, and quality. Needs often vary depending on the project phase, regulatory requirements, and the organization’s specific circumstances, and we’re happy to help you find the right expertise for your specific project. Please feel free to contact us to discuss your current needs and available profiles. 

We have experience with projects related to technology transfer, process optimization, and scale-up from development to stable production. Our consultants help establish structure and coordination across functions to ensure quality, traceability, and efficient transitions throughout the entire process. 

Absolutely. We offer experienced project managers and interim professionals who can quickly step in to support your operations during situations such as resource shortages, change initiatives, or critical project phases. Our consultants are accustomed to working in regulatory environments with high standards for quality and delivery. 

We use clear project structures, risk-based planning, and continuous monitoring to ensure transparency and predictability throughout the project. Our focus is on identifying risks early on, creating realistic plans, and ensuring progress in complex environments. 

Yes, many of the projects we run involve multiple functions, such as QA, production, laboratories, engineering, IT, and operations. We help organizations establish clear structures, define responsibilities, and improve communication to ensure progress and efficient decision-making processes. 

We take a structured approach, focusing on governance, risk management, documentation, and clear follow-up throughout the project lifecycle. Our project managers have experience navigating complex regulatory environments and ensuring that projects move forward without compromising on quality or compliance. 

We carry out projects in areas such as Pharma, Medtech, laboratory operations, and industry, where regulatory requirements, quality, and traceability are central to implementation. These may include, for example, technology transfers, investment projects, process changes, scale-up or the implementation of new work methods and systems. 

Yes, we have experience with various types of regulatory assignments within Medtech and life sciences, and some client case studies are already featured on our website. At an initial meeting, we’d be happy to tell you more about similar projects, our experiences, and how we’ve helped other organizations navigate regulatory requirements and market access over time. 

We have extensive experience in regulatory work within the medical devices sector ( Medtech ) and regulated industries. Our consultants have worked on everything from technical documentation and engagement with regulatory authorities to market access, post-market issues, and regulatory strategies for products in various risk classes and markets. 

What sets us apart is our combination of regulatory expertise, technical understanding, and a hands-on approach. Our consultants have experience in development, quality assurance, and regulatory processes, and understand how regulations impact business operations in practice—not just on paper. We focus on solutions that are sustainable, pragmatic, and tailored to our clients’ specific circumstances. 

We work closely with the business and integrate Regulatory Affairs into product development, quality assurance, and business strategy. Our consultants often collaborate cross-functionally with teams such as R&D, QA, clinical teams, and management to ensure that regulatory requirements are addressed proactively and effectively. 

Yes, we support companies in their work on regulatory strategies, classification, technical documentation, and submissions to facilitate effective market access. Our focus is on creating structure and clarity throughout the entire process to reduce regulatory risks and avoid unnecessary delays. 

We handle regulatory issues related to European, U.S., and global markets and have experience with, among other things, the MDR, IVDR, FDA, and international regulatory processes. Our consultants help organizations translate complex regulations into practical and business-oriented strategies. 

We help organizations navigate regulatory requirements throughout the entire product lifecycle—from development and market entry to aftermarket and change management. Our consultants provide both strategic and operational support in areas such as regulatory strategy, technical documentation, engagement with regulatory authorities, and compliance. 

Yes, we have consultants with experience in auditing, quality management, and regulatory requirements within regulated industries. Needs may vary depending on the organization, project, and audit phase, and we’re happy to help you find the right support based on your specific circumstances. Please feel free to contact us to discuss your current needs and the expertise available for your specific business.

Absolutely. Many organizations need support during periods of high workload, government inspections, or major change initiatives, for example. Our consultants can step in and provide support in areas such as auditing, supplier management, CAPA, quality management, and regulatory compliance, depending on the organization’s needs. 

We view audits as a strategic tool for business development and focus our work on improvement, efficiency, and quality. Through clear methodologies, an understanding of business operations, and regulatory expertise, we help organizations translate audit findings into concrete and sustainable improvements. 

Mock audits and GAP analyses are used to identify risks, nonconformities, and areas for improvement prior to external audits or regulatory inspections. This gives the organization the opportunity to strengthen its processes, documentation, and work practices before an actual audit is conducted. 

We help organizations identify root causes, prioritize actions, and establish sustainable CAPA processes that strengthen quality and compliance over time. The focus is on creating improvements that work in practice and contribute to long-term results—not just on closing out nonconformities. 

Yes, we conduct both internal audits and supplier audits with a focus on quality, compliance, and improvement. The audits are tailored to the business’s regulatory requirements, processes, and risk profile to generate relevant insights and concrete recommendations for improvement. 

We provide audit services in areas such as life science, Medtech, laboratory operations, and manufacturing. Our consultants have experience working in accordance with standards such as GMP, ISO standards, MDR, and IVDR, as well as conducting audits in complex and regulatory-driven environments. 

We help organizations prepare for internal and external audits by providing structure, planning, and quality assurance for processes and documentation. Our consultants offer both operational and strategic support to ensure audit readiness and mitigate regulatory risks. 

Yes. We’d be happy to tell you more about how we’ve helped manufacturing companies streamline planning, improve delivery accuracy, and create smarter production flows through scheduling and APS solutions. Please get in touch, and we’ll be happy to share relevant case studies and insights.

Yes. We help businesses integrate scheduling solutions with, for example, ERP, MES, and production systems to create a cohesive flow of information and better conditions for data-driven production.

We work closely with the business to understand its processes, challenges, and goals before implementing a solution. Our teams provide support throughout the entire journey—from analysis and strategy to implementation, integration, and further development of scheduling solutions and APS platforms.

With "what-if" features, you can test different planning options before making a decision. This provides peace of mind and makes production more flexible in the event of unexpected occurrences.

Rule-based and automated planning reduces set-up times and increases capacity utilization in production. Plans can be adjusted in real time, making the entire supply chain faster and more reliable.

APS eliminates manual labor and simplifies scenario planning. You can quickly reschedule in case of changes, identify material shortages in advance and communicate exact delivery dates - reducing dependency on key personnel.

An advanced scheduling solution (APS) optimizes machine utilization based on setup time matrices and capacity calendars. This results in better resource utilization, shorter lead times and a more stable production flow without bottlenecks.

Scheduling is the detailed planning of production - deciding when and how to run different orders, taking into account resources, machine capacity and available materials. An effective scheduling solution minimizes set-up times, maximizes output and increases delivery accuracy.

Yes. We’d be happy to tell you more about how simulation and virtual commissioning are used to optimize production flows, reduce risks, and ensure quality in industrial projects. Please feel free to contact us, and we’ll share relevant experiences and examples from past projects.

Yes. Simulation is often used to train operators and technicians in a safe and risk-free environment. This makes it possible to practice both normal and unusual scenarios without affecting actual production.

We work closely with the business to understand its processes, goals, and challenges before designing a solution. Our teams provide support throughout the entire process—from analysis and modeling to implementation, testing, and further development—to create long-term, sustainable, and effective solutions.

Simulation is particularly useful for detecting problems that are difficult to predict, such as bottlenecks, failures in control systems, or the impact of new investments on capacity. It also allows staff to be trained in virtual environments to reduce the risk of mistakes when production starts.

Simulation involves creating a digital replica of a production process to test and analyze changes before they are introduced in reality. This could be to evaluate new machines, process flows or layout changes. Through simulation, companies can avoid costly errors and improve efficiency.

Virtual commissioning is a process where control systems and production equipment are tested and validated in a digital environment before physical installation. This reduces lead times and the risk of errors at start-up, as many issues can be resolved before the machines are even assembled.

Simulation can be used to perform what-if analyses to see how different scenarios affect production, robustness tests to ensure that systems can cope with variations, and capacity analyses to identify bottlenecks and optimize flows.

Popular simulation platforms include AnyLogic, SIMIT, gPROMS and COMOS Walkinside. They differ in focus and features. Some are better at process simulation, others at 3D visualization or system integration. The choice depends on the type of production and process to be simulated.

Yes, absolutely. We have experience working with companies in the pharmaceutical, energy, process, and manufacturing industries, among others, where we have helped clients achieve better control, greater transparency, and more data-driven quality processes. Our clients in this area include, for example, AstraZeneca, Oatly, OKQ8, SSAB, and Stockholm Exergi.

Please feel free to contact us, and we'll tell you more about relevant experiences, approaches, and how similar challenges have been handled in practice.

We offer specialized expertise in areas such as MES, integration, quality processes, data analysis, and industrial IT. Our consultants can provide support for strategic initiatives, transformation projects, and day-to-day operations, depending on where the need arises.

In some projects, we provide a specialist; in others, we provide an entire team that works closely with the client’s organization over time.

We combine specialized expertise in industrial digitalization, integration, data management, and production to create solutions that work both technically and operationally. Our teams work closely with the business throughout the entire process, from analysis and strategy to implementation, integration, and further development.

The goal is always to create solutions that add real value to everyday life—not just new systems.

We help organizations create solutions that support traceability, documentation, and data integrity in accordance with their specific requirements and standards. Our consultants have experience in both industrial and regulated environments where quality, transparency, and compliance are mission-critical aspects of production.

By collecting and analyzing production data in real time, it becomes possible to identify deviations as soon as they occur, rather than after the fact. This enables businesses to respond more quickly to quality issues, reduce scrap, and avoid costly production disruptions.

We work closely with the business to understand processes, quality requirements, and information flows before designing the solution. This often involves linking data from production, quality systems, MES, ERP, and automation platforms to create a coherent and reliable chain of traceability.

Every production environment is different, which is why we always tailor our solutions to the business’s needs, regulatory requirements, and technical conditions.

Digital traceability makes it possible to track materials, processes, and production data throughout the entire value chain in real time. This provides better control over deviations, faster root cause analyses, and greater transparency in production—while also making quality management more proactive and data-driven.

Yes, we have consultants with experience in technical documentation, regulatory requirements, quality assurance, and medical devices in various risk classes. Requirements often vary depending on product phase, regulatory requirements, and internal resources, and we’d be happy to help you find the right support based on your situation. Please feel free to contact us to discuss your current needs and the expertise we can offer. 

Yes, we offer support in labeling, IFU, and post-market documentation , and related regulatory requirements. We help companies ensure that their documentation and labeling are up to date, traceable, and tailored to relevant markets and regulations. 

We take a pragmatic approach and tailor the documentation to the product’s risk class, regulatory requirements, and the organization’s needs. Our goal is to create clear, complete, and auditable documentation that works in practice and remains sustainable over time. 

Absolutely. We help organizations handle inquiries, feedback, and requests for additional information from notified bodies and the FDA, as well as prepare documentation for audits, submissions, and regulatory reviews. Our consultants have experience in both operational and strategic regulatory work. 

Yes, we support organizations in their transition from previous regulations to the MDR and IVDR, including gap analyses, remediationefforts, and updating technical documentation. The focus is on creating sustainable structures that work in the long term and stand up to scrutiny. 

We specialize in technical documentation within both European and global regulatory frameworks, including the MDR, IVDR, and FDA. Our consultants have experience tailoring documentation structures and regulatory strategies based on the product, risk class, and market requirements. 

We help organizations structure, develop, and maintain technical documentation in accordance with applicable regulatory requirements. Our consultants provide support throughout the entire product lifecycle, from classification and development to revisions, interactions with regulatory authorities, and aftermarket activities. 

Yes, absolutely. We’d be happy to tell you more about how we’ve helped companies in the industrial, energy, and life sciences sectors streamline production, modernize automation environments, and create better decision-making support through industrial digitalization.

Please feel free to reach out, and we’ll share relevant experiences, approaches, and examples based on the challenges and goals you’re working on today.

We have extensive experience in mission-critical and regulated environments where quality, safety, and traceability are central to production. Our solutions are designed with a focus on robustness, availability, and long-term sustainability—both technically and operationally.

Needs vary from one business to another and often change over time. That’s why we take a flexible approach—sometimes working with a single specialist consultant, sometimes with entire teams, and sometimes through long-term partnerships.

We always try to find an approach that suits the business, the organization, and the phase the client is currently in.

We offer specialized expertise in areas such as automation, OT, integration, manufacturing, data analysis, and industrial digitalization. Our consultants work both to bolster existing teams and on larger transformation projects that require collaboration across multiple areas of expertise.

We help businesses make production data more accessible and usable through integration between OT, MES, SCADA, and business systems. This creates greater transparency, faster monitoring, and better decision support for both operational teams and management.

For many customers, real-time data also serves as an important foundation for further initiatives in AI, optimization, and predictive maintenance.

Many organizations face the challenge of having older systems coexist with new digital solutions. We help customers modernize and future-proof their production environments step by step through upgrades, integration, and smarter information flows—all while maintaining a focus on operations and production throughout the process.

We work closely with the business to understand processes, technical dependencies, and operational goals before designing the solution. Our consultants have experience in both the manufacturing industry and regulated environments where requirements for availability, quality, and safety are high.

This can range from modernizing existing automation environments to new digital initiatives in production, integration, and data management.

Industrial digitalization creates better conditions for more stable production, higher quality, and more efficient use of resources by integrating automation, real-time data, and production-related systems. When production, data, and people work more closely together, it also becomes easier to make faster and more informed decisions.

Yes. We’d be happy to tell you more about how we’ve helped companies in the manufacturing and process industries streamline maintenance work, improve availability, and create better decision-making support through integration, data analysis, and digital maintenance solutions. Please feel free to contact us, and we’ll share relevant experiences and case studies.

Yes. We work both on specific projects and as a long-term partner in management and further development. Our teams are tailored to the organization’s needs and can quickly provide support in the event of changes, resource needs, or new initiatives.

We offer both specialized expertise and flexible consulting solutions tailored to your business needs. Our consultants can provide support in everything from strategic initiatives and projects to operational support, system management, and further development in the areas of maintenance and industrial digitization.

We work closely with the business to understand processes, the production environment, and technical dependencies before designing the solution. Our teams provide support throughout the entire journey—from analysis and strategy to implementation, integration, and the ongoing development of maintenance processes and system support.

We work with the integration, structuring, and quality assurance of maintenance data to ensure that the right information is available throughout the entire lifecycle—from fault reporting and work orders to analysis and follow-up.

We help businesses use production and equipment data to identify patterns, monitor equipment status, and develop more proactive maintenance strategies. The goal is to optimize availability, reduce costs, and extend the service life of critical assets.

We help businesses integrate maintenance systems with, for example, MES, SCADA, ERP, and automation platforms to create better information flows and access to real-time production data. This provides a better basis for decision-making and more efficient maintenance processes.

By collecting and analyzing data from production and equipment, businesses can identify anomalies and maintenance needs earlier. This creates better conditions for predictive and condition-based maintenance, which reduces the risk of unplanned downtime and disruptions to production.

Yes, we have consultants with experience in CSV ( data integrity), regulatory requirements, and the validation of computerized systems within regulated industries. Needs often vary depending on the system, project phase, and regulatory complexity, and we’re happy to help you find the right support based on your specific situation. Please feel free to contact us to discuss your current needs and the expertise we offer. 

We take a hands-on approach and tailor our validation work to the organization’s system environment, risk profile, and operating methods. The goal is to create sustainable processes that support both regulatory compliance and effective system management over time. 

Absolutely. We conduct GAP analyses against regulatory requirements and provide support in the development of, for example, validation plans, risk analyses, test documentation, and traceability matrices. The focus is on creating clear and auditable documentation that will serve the organization well in the long term. 

We help organizations ensure data integrity and traceability throughout the system’s entire lifecycle, with a focus on regulatory requirements, system controls, and documentation structure. Our consultants have experience working with critical systems where secure data handling is essential for quality and compliance. 

Yes, we help organizations manage validation during system updates, migrations, and changes to existing environments. Our consultants ensure that changes are documented, risk-assessed, and implemented in accordance with regulatory requirements and established change controlprocesses. 

We take a risk-based approach that focuses on the system’s critical functions, data integrity , and regulatory implications. By tailoring the scope and documentation to the level of risk, we help organizations create effective and sustainable validation processes without unnecessary administrative burdens. 

We provide validation services for computerized systems in accordance with established regulatory frameworks and guidelines such as GAMP 5 and GxP. Our consultants have experience translating regulatory requirements into practical, risk-based validation strategies in complex IT and operational environments. 

We help organizations plan, implement, and further develop the validation of computerized systems in regulated environments. Our consultants provide support throughout the entire system lifecycle—from requirements gathering and implementation to change management, operations, and upgrades. 

Yes, we have consultants with experience in process validation, method validation, equipment qualification, and regulatory requirements in regulated industries. Needs often vary depending on the production environment, project phase, and internal resources, and we’re happy to help you find the right support based on your situation. Please feel free to contact us to discuss your current needs and the expertise we offer. 

We work across functions and have experience coordinating efforts between production, QA, engineering and laboratory operations. This creates better conditions for effective validation processes where requirements, equipment, and work methods are synchronized throughout the entire project. 

Absolutely. We assist with the development and review of, for example, validation plans, risk analyses, protocols, reports, and traceability documentation. Our consultants ensure that the documentation is clear, auditable, and tailored to the regulatory requirements of your organization. 

We focus on creating sustainable and reproducible processes through clear validation strategies, structured documentation, and monitoring of critical parameters over time. The goal is to ensure consistent quality and reduce the risk of deviations and production disruptions. 

Yes, we support operations during changes in processes, equipment, and analytical methods, as well as when there is a need for revalidation. Our consultants help ensure that changes are risk-assessed, documented, and implemented in a controlled manner in accordance with regulatory requirements. 

We take a risk-based approach, focusing on critical quality attributes (CQA), critical process parameters (CPP), and the parts of the process that have the greatest impact on quality and patient safety. This ensures an effective validation effort with the appropriate level of testing and documentation. 

We have experience with equipment qualification in accordance with IQ, OQ, and PQ in areas such as production, laboratory operations, and life sciences. Our consultants provide support in everything from requirements definition and test strategy to implementation, documentation, and follow-up. 

We help organizations plan, implement, and further develop the validation of processes, equipment, and analytical methods in regulated industries. Our consultants work closely with operations, focusing on reproducibility, traceability, and long-term process stability. 

Yes, we have consultants with experience in cleanroom validation, environmental monitoring, equipment qualification, and GMP-regulated production environments. Needs often vary depending on the business, project phase, and regulatory requirements, and we’re happy to help you find the right support based on your specific situation. Please feel free to contact us to discuss your current needs and the expertise we offer. 

We work across functions and have experience coordinating work between production, QA, engineering and facilityfunctions. This creates better conditions for effective validation efforts where technology, quality, and regulatory requirements work together in practice. 

We take a structured approach to critical parameters such as ventilation, pressure, temperature, and environmental conditions to create stable and reproducible environments over time. Through clear documentation, monitoring, and risk-based work methods, we help organizations maintain control throughout the entire lifecycle. 

Absolutely. We help organizations analyze deviations, identify root causes, and implement measures related to, for example, environmental control, documentation, and hygienic design. The focus is on creating sustainable improvements that enhance both quality and audit readiness. 

We help organizations establish and further develop environmental monitoring programs focused on particulate matter, microbiology, and critical environmental conditions. Our consultants take a risk-based approach to ensure that monitoring and control are tailored to the organization’s processes, risk profile, and regulatory requirements. 

Yes, we support organizations in the planning and implementation of retrofitting to ensure continued compliance and functionality over time. This work includes, for example, risk assessments, test strategies, documentation, and monitoring of critical parameters in the operational environment. 

We specialize in validation and qualification in GMP-regulated environments, including Pharma, Medtech , and laboratory operations. Our consultants have experience with cleanroom classification, environmental monitoring, contamination control, and regulatory requirements related to critical production environments. 

We help organizations plan, implement, and follow up on the validation and qualification of equipment, facilities, and cleanrooms in regulatory-compliant operations. Our consultants address both technical and quality-related aspects to ensure stable operations, controlled environments, and regulatory compliance. 

We focus on quality, efficiency, and sustainable practices over the long term. By combining risk-based approaches, regulatory expertise, and practical implementation, we help organizations create robust processes that reduce risk, enhance quality, and simplify future changes and audits. 

Yes, we have experience with a wide range of projects in regulated industries, and several client case studies are already featured on our website. At our first meeting, we’d be happy to tell you more about similar projects, our experiences, and how we’ve helped other organizations with validation, verification, and regulatory quality assurance. 

Yes, we assist organizations that need to strengthen their teams with the right expertise in validation, verification, and quality assurance. Whether the need relates to a specific project, specialized expertise, or a larger change initiative, our focus is always on quickly finding the right solution and the right consultant profile based on the organization’s needs. 

We have extensive experience supporting regulated businesses in the areas of validation, quality, and compliance. Our consultants have worked on everything from complex validation projects and regulatory requirements to quality assurance and production-related improvement initiatives in sectors such as life sciences, Medtech , and industry. 

What sets us apart is our combination of regulatory expertise, technical understanding, and a practical, business-oriented approach. Our consultants have experience in real-world production, laboratory, and quality control environments and understand both the regulatory framework and the practical challenges of day-to-day operations. We focus on solutions that are sustainable, effective, and tailored to the realities of your business. 

We take a structured, risk-based approach, focusing on creating sustainable processes that work in practice—not just on paper. Our consultants provide support throughout the entire lifecycle, from planning and requirements definition to implementation, documentation, follow-up, and continuous improvement. 

We provide support in several areas related to validation and verification, such as CSV, process and method validation, equipment qualification, product verification, and validation of production and laboratory environments. Our consultants work at both the strategic and operational levels, depending on the needs of the business. 

Validation and verification involve ensuring that systems, processes, equipment, and methods function as intended and meet regulatory requirements over time. It is a central part of quality assurance in areas such as life sciences, Medtech, laboratory operations, and manufacturing, where quality, traceability, and patient safety are critical.