PIC/S Annex 11 – Computerised Systems
Annex 11 – Computerised Systems
PIC/S Annex 11 relates to the specific GMP requirements for the use of computerised systems in GMP.
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 GMP regulated activities. This module describes the relationship between Annex 11, 21 CFR Part 11 and ISPE GAMP5 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
Allow 1 to 1.5 hours to complete this course.