Revalidate the changed version: What is required before approval?
Code changes can alter behavior; the new version must be evaluated before approval rather than inheriting old evidence.
The question
A manufacturing quality model is replaced with a new version that changes its feature-processing code but retains the same stated purpose. The release team has only the previous version’s validation report. What is required before approval?
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- Revalidate the changed version ✓A changed model version requires evaluation against applicable acceptance criteria because prior evidence does not establish current behavior.
- Obtain the supplier’s assurance of equivalent performanceSupplier assurance is scoped evidence and cannot substitute for organization-specific validation against manufacturing acceptance criteria.
- Monitor production outcomes after releasePost-release monitoring is important, but it does not replace preapproval contextual evaluation of the changed version.
- Reuse the previous validation reportThe earlier report documents another version and cannot establish performance, robustness, or impacts after feature-processing changes.
The trap
Same purpose does not mean same behavior; version changes can invalidate earlier performance evidence. How to remember it
Code changes can alter behavior; the new version must be evaluated before approval rather than inheriting old evidence.
How many of these would you get right?
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