Annex 11 – Computerised Systems – 2020

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computerized systems

This interactive e-Learning module covers the GMP regulations relating to the risk based approach to computerised systems validation. This module is essential for all manufacturing, engineering, quality and IT personnel who validate or use computerised systems as part of GMP regulated activities.

 Annex 11 applies to all forms of software and hardware used as part of a GMP regulated activities. This module describes the relationship between Annex 11, 21 CFR Part 11 and ISPE GAMP guidelines.

The objectives of this training module are:

  • to provide an understanding of the regulatory expectations for computerised systems
  • to provide an understanding of risk management
  • to provide an understanding of electronic records, signatures and audit trail
  • to provide an understanding of tasks and deliverables for computerised system validation