Standard Release Documents (2026.2)

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) AG_SPOR_2026.2.0.0_Pre-Validation Plan.pdf	Defines scope, strategy, milestones, team structure, and deliverables for the validation cycle
User Requirements Document (URD) AG_SPOR_URD.pdf	Captures approved, incremental business, functional, regulatory, and security requirements
Risk Analysis (RA) AG_SPOR_RA.pdf	Assesses risk to patient safety, product quality, and data integrity using probability, severity, and detectability parameters
Traceability Matrix (TM) AG_SPOR_TM.pdf	Maps user requirements to corresponding OQ scripts to ensure complete coverage
Pre-Validation Summary Report (PVSR) AG_SPOR_2026.2.0.0_PVSR.pdf	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.