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What LCMS system changes warrant test method re-validation?

Posted: Thu Mar 24, 2022 8:43 pm
by vickig
FDA Bioanalytical Method Validation Guidance 2018 is clear that "Change in detection system" or "Changes in instrument software and/or software platforms" to a previously validated test method require a partial re-validation (p.11).

The question is what specific LCMS system changes should trigger re-validation and let's get granular here. I am referring specifically to test method validation within a single facility, not system validation or method transfer. For example:
Does a software upgrade to a newer version trigger method revalidation?
Change in software?
Change in model or version of system components (pump, autosampler, detector)?
Upgrade to OS?
anything else you can think of

Thanks for your input