Package includes the computer system validation templates for developing Plans, Specifications, Protocols and Reports in accordance with FDA (21 CFR Part 11), EMA and Annex 11 requirements for Computer system validation and most importantly, adopts the latest thinking on a risk based approach to computer systems validation as recommended in GAMP 5.
The following templates are included:
- Periodic Review Checklist
- Design Specification (DS)
- Functional Requirement Specification (FRS)
- Installation and Operational Qualification (IOQ)
- Project Validation Plan (PVP)
- Traceability Matrix (TM)
- User Requirements Specification (URS)
- Validation Final Report (VFR)