What the Validation Plan Does
The Validation Plan (VP) is the master document that defines the entire scope, strategy, and approach for validating a system. It is written and approved before any other validation document — before the URS is finalised, before protocols are written, before testing begins. It is the document that a QA reviewer reads first to understand what was done and why.
Think of it as the project brief for your validation. It answers the foundational questions: what is being validated, what regulations apply, what GAMP 5 category is the system, what documents will be produced, who will produce them, and what the acceptance criteria for successful validation are.
The Validation Plan must be approved before design documents are written. A VP approved after the FDS is already complete is a retrospective justification — not a plan. QA reviewers look at approval dates. If the VP is dated after the URS, it's a finding.
The 12 Sections Every VP Must Contain
The GAMP 5 Category Section — Why It's the Most Important
The GAMP 5 category section of the VP documents the classification decision for your system and the rationale behind it. This is not a formality. The category you assign determines which documents are required, how deep the OQ must go, and whether a Software Design Specification is needed.
The classification rationale should answer: what type of software is this? Has it been configured for this specific application? Does it involve custom code? The rationale should be one short paragraph, not a table. It should be specific enough that a QA reviewer reading it six months later can reconstruct why the decision was made.
The Document List — What to Include for Cat 4
For a Category 4 PLC/SCADA system, the standard document list in the VP is:
- Validation Plan (this document)
- User Requirements Specification — see our URS writing guide
- Functional Design Specification — see our URS vs FDS guide
- Hardware Design Specification
- Risk Assessment
- Supplier Assessment Questionnaire and Report
- Factory Acceptance Test protocol — see our pharma FAT guide
- Installation Qualification protocol
- Operational Qualification protocol
- Performance Qualification protocol
- Traceability Matrix — see our traceability matrix guide
- Validation Summary Report
The Acceptance Criteria Section
The acceptance criteria section defines when the validation is complete and the system can be released for production use. Typical acceptance criteria for a Cat 4 system:
- All IQ, OQ, and PQ test cases executed with PASS verdict or formally justified deviation closure
- All Critical and High risk functions have no open deviations
- Traceability matrix is 100% complete — every URS requirement has at least one closed test case
- All validation documents reviewed and approved by QA
- VSR completed and approved
Deviation Management — Define It Before Testing Starts
The VP must define how deviations will be classified and managed before the first test case is executed. The classification should at minimum cover: Critical (system cannot be released until resolved), Major (must be resolved before validation close), and Minor (can be resolved post-release with documented rationale and risk acceptance).
Defining this in the VP prevents the situation where a deviation is found during OQ and there's no agreed process for deciding whether it blocks release — a situation that leads to very uncomfortable conversations with QA under time pressure.
The Validation Plan template is pre-structured with all 12 sections including the GAMP 5 category rationale template, document list table (pre-populated for Cat 3 and Cat 4), roles matrix, and deviation classification table. It integrates with the other templates — document IDs, version formats, and naming conventions are consistent across the full document set.