Compliance & Assurance
Risk-based validation without paperwork fatigue
How to keep validation evidence lean, focused, and aligned to intended use.
TL;DR
Risk-based validation keeps evidence aligned to real risk and intended use. It avoids documentation overload by focusing on what must be controlled, tested, and reviewed.
When you need this
- Validation packages are bloated or inconsistent.
- Teams feel overwhelmed by documentation effort.
- Audits reveal gaps in traceability or risk rationale.
Key concepts
Risk-based scope: the smallest set of requirements, tests, and controls that protect intended use.
Evidence reuse: artifacts that serve both operational and audit needs.
Control alignment: linking validation work to access, change, and incident practices.
Common mistakes
- Documenting every possible test without risk justification.
- Separating validation from operational controls and ownership.
- Failing to keep evidence current after go-live.
Practical checklist
- Define intended use and quality impact clearly.
- Maintain a concise risk assessment tied to requirements.
- Link each test to a risk and a requirement.
- Embed change and access control into validation plans.
- Schedule periodic evidence review to prevent drift.
Related services
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