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QUALITY MANAGEMENT

We provide quality assurance expertise and services to the Life Science industry and beyond.

By developing clear strategies based on a risk management approach we can help you to meet your business objectives with the optimal use of resources. In short, we help you to improve quality while lowering your costs and shortening your lead times.

We can provide QA resources on a daily basis to support ongoing operations, as well as support wider process improvement initiatives. For example, providing quality assurance for integrated IT, LIMS and automation solutions. 

Whatever the task, your success is our priority. Helping to achieve this are ourthree core values;
Trust, Commitment and Results.


  Quality assurance specialists

Our QM team is made up of quality assurance specialists with extensive experience gained from the Life Science industry – primarily within pharmaceutical and medical device companies. But we also have experience in other areas, such as veterinary medicine and cosmetics.

We are able to support your organization across a wide range of quality assurance areas, including:

 

  • Computerized systems
  • Development of quality management systems
  • GAP-analysis/quality mapping
  • Batch release - delegated QP
  • Project QA
  • Change control
  • Complaints
  • Deviations
  • CAPA
  • Development of SOPs
  • Product security/serialization

 

 

  Validation, qualification & verification services

Our consultants can develop complete validation strategies (comprising planning, protocols, records and reports), as well as lead and perform testing and validation activities. We also offer requirement management, design qualification and similar services.

We have built up extensive validation and qualification experience across a wide range of areas, including automated and computerized systems (e.g. MES, LIMS, DCS, SCADA, IS/IT), laboratory equipment, process equipment, and administrative systems.

 

  • Computerized systems
  • IT infrastructure
  • Production equipment
  • Laboratory equipment
  • Process
  • Media incl. WFI
  • Controlled facilities (temperature, humidity, light)
  • Excel sheets

 

  Inspection & auditing services

We offer supplier assessments and other inspection/auditing services according to specific quality standards and guidelines, including GMP, GAMP, ISO 9001:2008, ISO 17025, Tick-IT, and Sarbanes Oxley (SOx).

We can also carry out internal, on-site audits and periodic reviews of systems, equipment and products.

Our inspection and auditing experts are able to identify critical issues with great precision and then recommend both short and long-term actions. Please contact us if you would like to know more about our services.

 

  • Supplier evaluation
  • Internal audits
  • Support during regulatory inspections
  • Periodic review of systems and products

 

  Quality experts and project leaders


We can supply quality experts and project leaders who have built up many years of experience working with quality assurance and validation projects.

By organizing workloads and ensuring resources are allocated where they are most needed, we can help you to reduce costs, minimize risk, and improve quality – all whilst still complying with regulations and the local laws affecting your business.

Our quality experts can, for example, develop and implement effective quality management systems according to relevant standards, guidelines and regulatory requirements. They can also plan, direct and perform risk assessments, as well as perform GAP-analyses.

 

  • GAP-analysis/quality mapping
  • Product security
  • Serialization

 

  PlantVision Academy

We offer a range of training courses, seminars and workshops for different sets of quality regulations and guidelines.
As well as offering open courses, we can also provide customized training for your organization.

Example subjects include:

 

  • GAMP 5
  • Data integrity
  • Validation of computerized systems
  • How to execute formal testing (verification)
  • Serialization 
  • Periodic review of systems
  • Basic GxP
  • Customized courses


Find upcoming training opportunities here » (Swedish only)

 

  QA HelpDesk

Through QA Helpdesk you can get temporary help and support from a personal QA contact.
This service can provide support across a range of areas, including:

  • QA operations support
  • Project-related services (IT, processes, production and lab)
  • Subscription service for updates in regulations
  • Quality audits and inspections
For more information, read our information sheet: QA HelpDesk (pdf - Swedish only) »


Or, contact the QM Team »

 

  Customer success stories

The shortest course to quality assurance

Computerized systems used in GxP environments have to meet regulatory demands. Training courses run by The Swedish Academy of Pharmaceutical Sciences aim to help participants understand not only how to carry out quality assurance of computerized systems, but how to do so efficiently. That’s why they use consultants from PlantVision as course tutors.

Read more »

Quality built on courage

When you are up against tight deadlines it takes courage to stick to your own line of thinking. This proved to be a key success factor during the validation of Uppsala Imanet's new production line for the manufacture of radioactive tracers.

Read more »

Getting to grips with GAMP

When your medical tubing products are helping to save lives around the world, staying on top of current issues is essential. A customized training course has strengthened Optinova's knowledge of GAMP, and provided a starting point for developing new quality processes.

Read more »

Knowing your supplier inside out

Knowing your supplier's capabilities is essential if you are to invest in a new business system. A competent supplier audit not only gave Recipharm the information they needed, but also generated solutions to quality issues and created a positive platform on which to move forward.

Read more »

Selecting the right quality partner

The introduction of GAMP5 meant Octapharma needed to review its systems and routines for its blood plasma production. By choosing the right partner it has achieved this and, at the same time, developed shorter and clearer QA and validation instructions.

Read more »

More customers,
past and present…


AstraZeneca  •  Akzo Nobel Pulp and Performance Chemicals  Elekta  •  Pfizer  •  Octapharma  Valneva  •  MEDA  •  Maquet  Replior  •  Sobi  •  Orexo
Kemwell  •  CCS Healthcare  Cobra Biologics

 

 

  Quality Management Team

Our Quality Management Team has broad combined knowledge covering GMP, GDP, GLP, ISO9001 and ISO13485. We also have some expertise in ISO17025, ISO22716 (Cosmetics), as well as specific skills in a number of other areas.

Want to join our team?
We’re always interested in hearing from experienced, ambitious and enthusiastic quality specialists. If you think you might be a perfect fit for our QM team, please forward your CV here »   

See current employment opportunities »

 

  How to get in contact

If you would like more information about our offering, or want to find out what we could do for you and your organization, please contact

Anna-Lena Mann
Business Area Manager, Quality Management, PlantVision AB
Tel. +46 (0)8 503 045 50
Send email »

PlantVision offices - contact info »

 

 

 


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