Validation

Objective Evidence: How to Document It to FDA’s Satisfaction

Q: Could you tell me what’s considered best practice when it comes to documenting objective evidence? A: First of all, remember that objective evidence is NOT the words “pass/fail”, “true/false”, “as expected”, or “yes/no”. They are conclusions. [pullquote align=”right” cite=”” link=”” color=”” class=””…

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Audit Trail Corruption: How to Correct and Document It

Q: We’re a laboratory software developer. Recently, while examining a customer’s data, we discovered some corruption in their audit trail data — a few duplicate records. We’re tracking down how this happened, and of course we will correct the root cause. However, my question…

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FDA’s Expectations for Software Traceability

Q: It’s my understanding that FDA standards and guidelines call for software traceability of the requirements down to the level of the code (modules and functions). However, I believe a lot of companies may not be able to demonstrate requirements traceability down to…

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