Top Tips When Recording Results in Validation Protocols

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Via Don Hurd @ askaboutvalidation

When executing test scripts all tests are performed as written and all expected results are met as described. In “real life” this is not always the case. Generally, though, there will be a mix of everything going as expected, something not right with the protocol, and expected results not being met. The following sections discuss what to record and how to record it and how to manage attachments (such as screen shots).

The Basics

As has been alluded to, the individual executing the test should somehow annotate each page where data was recorded indicating that he or she did, in fact, record that data. In addition, all the test equipment, the unit under test, and any setup should be recorded. In all cases, whatever is written down, record everything using Good Documentation Practices.

Annotations

Minimize annotations but don’t hesitate to make them if it helps clarify results or test efforts. If, for example, a test is stopped at the end of one day and resumed the next day, an annotation should be made to show where and when (day) testing stopped and where and when testing resumed. Similarly, if a test is performed by multiple testers, annotations should be made to show which test steps were performed by which tester.

Annotations should only be used to provide necessary explanations. Annotations should not be used for reminders, grocery lists, doodles while waiting for a test to complete, etc. This is especially relevant in regulated industries but pertinent to any industry to ensure a professional result.

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