Standard Documents
Standard documents are the core set of formally prepared, reviewed, and approved artefacts that form the Pre-Validation Kit.
The standard set of documents includes:
|
Document |
Purpose |
|---|---|
|
Pre-Validation Plan (PVP) |
Defines scope, strategy, milestones, team structure, and deliverables for the validation cycle |
|
User Requirements Document (URD) |
Captures approved, incremental business, functional, regulatory, and security requirements |
|
Risk Analysis (RA) |
Assesses risk to patient safety, product quality, and data integrity using probability, severity, and detectability parameters |
|
Traceability Matrix (TM) |
Maps user requirements to corresponding OQ scripts to ensure complete coverage |
|
Pre-Validation Summary Report (PVSR) |
Summarizes execution results, deferred defects, and the overall validation outcome |
These documents collectively ensure a consistent, traceable, and GAMP-aligned validation approach for every General Availability release hosted on cloud.