What the template covers
The workbook walks 11 VMP sections — from purpose and scope through risk-based approach, documentation standards and acceptance-criteria philosophy to schedule — each row pairing what the section must cover with a content/reference cell, an owner, and a Draft / In review / Approved / N-A dropdown, plus an Instructions tab and a worked example.
- The seven items EudraLex Vol 4 Annex 15 §1.5 expects a VMP to cover, expanded into eleven working sections
- What each section must cover, stated per row
- Risk-based approach and GAMP-category depth rationale
- Change and deviation handling during validation
- Periodic review and revalidation triggers, schedule and references
