Join us for a story of how smart cloud solutions and tailored validation and security strategies are helping businesses achieve their goals.
Smooth convergence between IT & OT - a challenge
Life science manufacturing companies, with advanced industrial processes, can face a range of challenges linked to growing complexity. Traditionally, IT systems have managed business data (e.g. ERP and MRP systems), while OT systems (such as SCADA and PLC) control the physical processes. However, with increasing demands for digitization and connectivity between systems, the lines between IT and OT are starting to blur.
The big question is: How to ensure effective integration without compromising security and validation? We will answer that now.
Holistic approach to validation & security was key
It is crucial to identify the needs and objectives of both IT and OT systems. Using our expertise in system validation, we can assist you in identifying which validation aspects are particularly critical for the different systems. The focus here is not only on technology choices, but also on important issues such as:
- Who owns the data?
- Where is the data stored and what happens if the provider goes bankrupt?
- How do we ensure that updates do not disrupt the operational environment?
Through careful risk assessment and requirements definition, the validation process can be tailored to your specific needs. For example, assessments carried out may show that certain parts of the systems can be validated separately, saving both time and resources.
Cloud solutions that provide flexibility without sacrificing control
Many customers have chosen to move to cloud-based solutions for their IT systems and in the process of choosing a solution to balance flexibility and security, we can act as a support. By carefully considering the pros and cons of single-tenant and multi-tenant environments, we help you and your company find a solution that fits your unique situation.
What are single-tenant and multi-tenant?
In a single-tenant environment, each customer has their own dedicated installation of a software or cloud service. This means greater security and the ability to customize to the customer's specific needs, but also that the customer is solely responsible for costs and maintenance.
In a multi-tenant environment, several customers share the same installation of a software or cloud service, with each customer's data kept separately. This results in lower costs and easier maintenance, but less opportunity for individual customization and some limitation in control over updates.
Questions that may arise during the process include
- How scalable is the solution and what happens to security when handling more users and larger amounts of data?
- How do we manage redundancy and ensure data integrity in a cloud platform?
Through close collaboration between you as the client and the cloud provider, a sustainable plan for updates is created, which includes test environments to minimize disruptions.
Successful digital transformation
With advice, guidance and expertise, we can help you implement a smooth integration between IT and OT, while the cloud-based solution can give you the flexibility you need to scale up your business, for example. Systems will be robust, secure and ready for future digital challenges.
Success factors include careful validation, risk assessments and close collaboration between all parties. Expertise, experience and the ability to customize solutions to your business needs lead to a sustainable, scalable and secure IT infrastructure that supports your growth and future innovations.
By combining technology, strategy and expertise, we ensure that you and your business achieve a successful digital transformation.
Key questions to reflect on for businesses in a similar situation:
- Have you ensured that the validation of your cloud solutions is sufficient and adapted to your risks?
- Are roles and responsibilities clearly defined in your Service Level Agreement (SLA) with the cloud provider?
- What is your strategy for managing future updates and changes in both IT and OT systems?
Is your company facing similar challenges in validation and qualification? Maybe you have started your journey towards Industry 4.0, but need support to reach your final goal? With your ambitions and our expertise, we will be able to take your company to the next level. Why not start today?
Contact me to find out more!
Lina Stange
Senior Expert Consultant
lina.stange@plantvision.se
PST! Expert tips on regulations and standards
- ISO 27000 series for information security: These standards address information security and cybersecurity, including requirements and guidelines for protecting digital assets. For more information, visit the Swedish Institute for Standards (SIS) and the official ISO website
- Eudralex vol 4 Annex 11: These rules apply specifically to computerized systems used in the manufacture of medicinal products in the EU and describe requirements for the management of computerized systems. You can find it here directly on the European Medicines Agency (EMA) website: Eudralex Annex 11
- FDA 21 CFR Part 11: These regulations address Electronic Records (ER) and Electronic Signatures (ES) in the pharmaceutical industry in the United States, focusing on requirements for validation and security. More information is available on the FDA website
- GAMP 5 (Good Automated Manufacturing Practice): This is a global guideline for the management of computerized systems in the pharmaceutical industry throughout its life cycle. You can read more on the ISPE website and you can also take a look at our Academy page where we offer several relevant trainings, not least in the GAMP Plantvision Academy: trainings and courses | Plantvision
- ISPE Concept Papers: These white papers describe specific topics and developments in industry best practice. The documents are available on the ISPE website
These resources provide you with the necessary information on rules and standards for safety and validation in the pharmaceutical and IT industries.
