Validation


QUALIMS - Validation

Part of our team is made up of validation experts and consultants who provide customers with solutions in the field of Quality (validation, qualification, etc...).

Technical Documentation

All our products have technical documentation consisting of the following :
  • Functional specifications describing the functions available and any constraints applying to them
  • User handbooks
  • Training literature.

Validation Documentation

The validation package is available as an option. This package was written to respect the strictest regulations and standards in force in laboratories.
This package is a validation guideline, providing our customers with a set of structured support documents.
It is delivered in the form of a CD-Rom with modifiable Word format files. We can also guide our customers throughout their validation process The validation package consists of the following :
  • Functional risk analysis
  • The validation plan (VP) defining the qualification outline, responsibilities and schedule
  • Installation Qualification (IQ) Documents :
    • The protocol for the installation qualification defining the IQ modalities in terms of :
      • perimeter
      • organisation, implementation and verification
      • IQ documents
    • IQ test scripts defining :
      • actions to be taken to check the installation and setup
      • organisation, implementation and verification
      • OQ documents
    • The IQ report reporting results obtained from executing test scripts and determining IQ conformity
  • Operational Qualification (OQ) Documents :
    • The operational qualification protocol (OQP) defining the OQ modalities in terms of :
      • perimeter
      • organisation, implementation and verification
      • OQ documents
    • OQ test scripts defining :
      • actions to be taken to check that the functions operate as intended
      • expected results
      • test compliance
      • script acceptance criteria
      • The OQ report reporting results obtained when implementing test scripts and determining OQ compliance
  • Performance Qualification (PQ) Documents :
    • The performance qualification protocol (PQP) defining the PQ modalities in terms of :
      • perimeter
      • organisation, implementation and verification
      • PQ documents
    • PQ test scripts defining :
      • actions to be taken to check system performance, data backup and restoration, the system security rules, administration and user documents as well as training (training plan, support, registration)
      • expected results
      • test compliance
      • script acceptance criteria
    • The PQ report reporting results obtained when executing test scripts and determining the PQ conformity
  • The final validation report (document template updated following the implementation of all qualification phases)