Transcript
Start with intended use
Do not decide validation from a product name, department, or cloud label. Describe who uses the system, what task it performs, which data or record it handles, and what decision relies on the output. That intended use establishes whether a GxP assessment is needed and where the regulated boundary begins.
Connect software to consequence
Ask what the software could do incorrectly and how that failure reaches the process. Could it release incorrect material, hide a required record, miscalculate a result, or bypass an approval? If there is credible regulated reliance, validate the affected use. If there is none, document the rationale instead of creating unnecessary protocols.
Assess functions separately
A platform can contain high-impact workflow controls and low-risk convenience features. Treating the whole system as one risk level weakens the strategy. Define the GxP functions, justify exclusions, and establish reassessment criteria. Validation is about the controlled use, not a blanket label on every feature.