Maintaining the validated state requires a current explanation of why the approved system use remains supported. This method connects claims, assumptions, evidence, owners, and events that could invalidate the conclusion.
Worked example
Completed example — fictional
Claim: The approved CAPA workflow preserves required review before closure.
Evidence: Configured rule review, branch and exception tests, access checks, and open-record transition tests.
Assumptions: The approved routing rules remain current; only controlled configuration is deployed; the identity mapping remains accurate.
Triggers: Routing change, privileged-access incident, unexpected closure, supplier engine update, or process redesign.
Owner: System owner coordinates reassessment with the process and quality owners.
Three events and their effect
A cosmetic text correction may leave the claim intact after impact assessment. A new API closure route requires new evidence. An incident showing unauthorized closure contradicts the claim and requires immediate evaluation of affected records and continued use.
Reusable worksheet
For each claim, record scope, evidence, assumptions, known issues, owner, last assessment, trigger, and required action. Link the controlled change and incident records rather than copying every detail.
Limit: Maintaining a dashboard of green indicators is insufficient if nobody checks whether the assumptions remain true. The method works only when operational events can change the conclusion.
Questions and discussion
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