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=”” size=””]The words “pass/fail”, “true/false”, “as expected”, or “yes/no” are conclusions.[/pullquote]

Objective evidence is actual data — what was seen; what occurred.

This can be a print-out, screen print, automated log of key strokes, or a screen video. It can be documented values or documented results.

Any change made to the final results should be done using proper error correction (single line-through, initials and date) or, if done electronically, via an audit trail.

For further information on FDA’s expectations, download the free EduQuest Compliance Advisory I wrote:
Understanding Objective Evidence: What It Is and What It Definitely Is Not.

Answered by Denise Dion, Vice President of Regulatory & Quality Services at EduQuest (18 years as an expert FDA investigator and a co-developer and trainer of FDA’s Quality System Inspection Technique-QSIT). Denise also is the lead instructor for EduQuest’s Design Control for Medical Devices training class.


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