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Life Sciences

 

Validation

The definition of ‘validation’: “Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”

Actemium’s approach for validation is based on the W-model, which is an adaptation of the traditional V-model.

 

Validation_EN

 

Based on the User Requirement Specification (URS), mostly provided by the customer, the Functional Design Specifications (FDS) and the Detailed Design Specifications (DDS) are established. The FDS explains how the system will operate. The DDS explains how the system will be built.

During the Design Qualification (DQ), we will verify if the proposed design (FDS and DDS) meet all the requirements defined and detailed in the URS. A satisfactory execution of the DQ is a mandatory requirement for the procurement and construction to start. After successful installation, commissioning can be started. In Actemium’s approach, commissioning includes:

  • Mechanical completion
  • Factory Acceptance Tests (FAT)
  • Site Acceptance Tests (SAT)

 

Once commissioning is successfully completed, the installation can be handed over to the customer for qualification, or Actemium can execute the Installation Qualification (IQ) and Operational Qualification (OQ) as well.

During the IQ, Actemium verifies if all quality requirements and specifications as defined in the URS are met, if the process or equipment is correctly installated as described in the design specifications, and if all required components and documentation needed for continuous operation are in place and installed.

During the OQ, Actemium checks if the installation is running in accordance with the functional design specifications and the functional quality requirements as specified in the URS.

Our approach meets all necessary regulations and standards:

  • ASME BPE
  • GAMP5
  • 21 CFR Part 11 – for rules on electronic records and signatures
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