Expertise Validation & Testing Commissioning & Qualification

Commissioning & Qualification

Achieving compliance with the rigorous GxP guidelines in the life sciences industry requires a deep understanding of processes, installations, and instruments throughout their life cycle. A proficient partner can help address challenges and ensure compliance with confidence.

In addition to years of practical experience, Agidens has the best knowledge of current industry practices and the latest developments in the area of GxP.

 

OUR APPROACH TO COMMISSIONING & QUALIFICATION

Our comprehensive approach encompasses all stages of the life cycle, ensuring that your equipment, cleanroom, computer systems, and more are fully prepared and compliant. We analyze, test, and validate processes, spaces, and labs, relying on years of practical experience and knowledge of industry best practices and the latest GxP developments.

  • Commissioning and qualification plan: developing the C&Q strategy, plan of approach, methodology, and ready-to-use templates
  • Pre-inspection checklists
  • Functional performance tests
  • Design reports
  • Training for operation and maintenance of systems

 

All our documents comply with good documentation practices, enabling them to be used for qualification purposes (leveraging).

 

OPERATIONS SUPPORT & RETIREMENT

During the operation of installations, various processes and equipment may undergo modifications. We provide the necessary know-how for related quality systems and processes such as change control, CAPA, and deviation management.

Upon retirement of a GxP installation, we offer decommissioning and data migration support, ensuring a smooth transition and continued compliance.

 

TAKE YOUR COMMISSIONING & QUALIFICATION TO THE NEXT LEVEL

Do you like our approach? We would love to hear from you!

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