Commissioning & Qualification

Commissioning, Qualification, Operations & Retirement

The GxP guidelines require a science and risk based life cycle approach for processes, installations and instruments. In other words, an essential part of process validation is demonstrating that the systems used (technical installation, equipment, software) are "under control throughout the life cycle.

In the life cycle of a system, we distinguish:
  • Design
  • Development and installation
  • Initial commissioning
  • Qualification
  • Operational use
  • Decommissioning
We can advice and assist you during all these phases: taking into account current industry practices and the latest developments in GxP supplemented with years of practical experience.

Commissioning processes

We offer services for several commissioning processes following Good Engineering Practices:
  • commissioning and qualification plan
    • developing the C&K strategy to be followed
    • development of plan of approach
    • setting up methodology, including the development of ready-to-use templates
  • checklist for inspections beforehand
  • functional performance tests
  • design reports
  • training for operation and maintenance of the systems
Our documents comply with the good documentation practices making it possible to use them for qualification purposes.

Qualification of installations and instruments

Our validation engineers are subject matter experts in qualification and verification of the following installations and instruments:
In compliance with GAMP5© and/or ASTM E2500.

Operations

During operation of the installation the various processes, installations and equipment are subject to all kinds of modifications. Agidens owns the know-how required for the related quality systems and processes such as:
  • Change Control
  • CAPA
  • Deviation management

Retirement

Upon retirement of a GxP installation you must take special care of the decommissioning, data migration, etc. Agidens can provide the necessary support in these domains as well.

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