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Checklist

The Complete GxP Validation Checklist — from URS to VSR

A single-page checklist of every artefact, every review gate and every regulator-facing evidence element in a modern V-model validation.

Cybroscape Technologies3 min read

Key takeaway

A single-page checklist of every artefact, every review gate and every regulator-facing evidence element in a modern V-model validation.

Part of our guide to GxP software — categories, evaluation criteria and how the platforms compare.

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  • Traceability matrixFor review
  • Validation summary reportFor review
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One requirements document goes in; a draft validation package comes out. Every deliverable waits for your team’s review before anything is approved.

The complete GxP validation checklist — every artefact, every review gate, every regulator-facing evidence element in a modern V-model validation. Save this page; use it in your next kick-off.

1. Governance

  • Validation Master Plan or programme-level plan (as applicable)
  • Roles and responsibilities matrix — including segregation of duties
  • System of record for controlled documents (see eQMS implementation)

2. Project-level planning

  • Validation Plan (VP)
  • GxP + GAMP classification with explicit rationale — see Classification Engine
  • Initial Risk Assessment

3. Requirements + design

  • User Requirement Specification (URS) with per-requirement Functional Risk Assessment
  • Design Specification (DS)
  • Configuration Specification (where applicable)
  • Interface / integration specs

4. Risk + strategy

5. Test protocols + execution

  • IQ protocol + report
  • OQ protocol + report
  • PQ protocol + report
  • Test case → step structure with evidence attached
  • Deviations with disposition and re-test lineage

6. Traceability + review

  • Live Requirement Traceability Matrix — coverage view, orphan-test view, readiness verdict (see Live RTM)
  • Multi-party review with quorum (see Human-in-the-Loop reviews)
  • Real 21 CFR Part 11 e-signatures on every approval (see 21 CFR Part 11)

7. Closure + ongoing

  • Validation Summary Report (VSR)
  • Periodic Review programme
  • Change Control programme (see Change controls)
  • Retirement plan for end-of-life systems
  • Tamper-evident audit trail available for inspection at any time (see Audit Readiness)

8. AI-specific additions where applicable (Annex 22)

  • Published AI governance
  • Frozen benchmark set that gates every release
  • Safeguards on AI outputs
  • Human-in-the-loop policy enforced by the tool
  • Drift monitor with defined escalation
  • Documented workflow fallback when AI is off
  • See Annex 22 assurance

Delivered as a service

Our CSV validation services team runs this end-to-end, and our CSA services team re-baselines legacy validation practice against the same checklist.

Where to go next

Explore GxP Copilot for AI-native validation, TraceDraft for source-traceable clinical documentation, or book a demo to see either on your own data.

See it on your own systemBring a URS or a system. We run GxP Copilot against it live on the call.

Sources

Primary documents referred to on this page, from their official publishers.

GxP validation checklistV-model checklistCSV checklistvalidation deliverables

Keep reading

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Buyer GuideGxP Software for Medical Device Companies: What Is Different From PharmaMedical device validation shares DNA with pharma but the regulatory framework, risk model, and product lifecycle are different. Here is what device teams need from GxP software. · 5 min readBuyer GuideGxP Software vs Spreadsheets: When to Make the SwitchMany pharma teams still run validation on Excel and SharePoint. Here is when that stops working, what it actually costs you, and how to migrate without losing your existing evidence. · 6 min readTrainingGxP Training Requirements: What Regulators Expect, How to Document It, and Where Most Teams FailThe complete guide to GxP training — regulatory basis (FDA, EMA, ICH Q10), training matrix design, SOP curriculum, competency assessment, and the documentation structure that satisfies inspectors. · 5 min readRegionalGxP Validation in Ireland: What Makes the Irish Pharma Manufacturing Hub DifferentIreland hosts 9 of the top 10 global pharma companies. Here is what makes validation in Irish pharma operations different — the HPRA inspection culture, multi-site complexity, and the talent gap that shapes every project. · 5 min readRegionalGxP Validation in Switzerland: What the Basel Pharma Cluster Expects From Its Validation PartnersSwitzerland is where Novartis, Roche, and Lonza set the global standard. Here is what GxP validation looks like when your neighbours literally wrote the quality playbook. · 5 min readRegionalGxP Validation in the UK: What MHRA Expects After BrexitHow GxP validation works in the United Kingdom today — MHRA's inspection focus, its data integrity guidance, where UK rules still track EU GMP and where they diverge, and what that means for validation teams. · 7 min readComplianceGxP vs GMP vs GLP vs GCP: What Each One Actually CoversA side-by-side breakdown of the GxP disciplines — what each regulates, where they overlap, which one applies to your work, and the boundary mistakes that create audit findings. · 8 min readAI ValidationHuman-in-the-loop is not a footnote: designing HITL that actually worksQuorum, segregation of duties, escalation, override auditing — HITL patterns that hold up under inspection. · 6 min read

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