05/27/2026
Quick compliance check for sample management systems:
Labs assume theyโre covered under FDA 21 CFR Part 11 if their systems log who made changes.
But thatโs only part of the story.
To be truly ๐ข๐ต๐ต๐ณ๐ช๐ฃ๐ถ๐ต๐ข๐ฃ๐ญ๐ฆ, a record should show:
โข ๐ช๐๐ข made the changes?
โข ๐ช๐๐๐ก did they make it?
โข ๐ช๐๐๐ง system did they use?
โข ๐ช๐๐ฌ were they authorized to make it?
That last point is often where the gap appears.
After nearly 40 years of helping labs prepare for FDA audits, we've found one question that consistently exposes them:
๐๐ฐ๐ธ ๐ฅ๐ฐ ๐บ๐ฐ๐ถ ๐ฌ๐ฏ๐ฐ๐ธ ๐ต๐ฉ๐ช๐ด ๐ฑ๐ฆ๐ณ๐ด๐ฐ๐ฏ ๐ธ๐ข๐ด ๐ข๐ถ๐ต๐ฉ๐ฐ๐ณ๐ช๐ป๐ฆ๐ฅ ๐ต๐ฐ ๐ฎ๐ข๐ฌ๐ฆ ๐ต๐ฉ๐ช๐ด ๐ด๐ฑ๐ฆ๐ค๐ช๐ง๐ช๐ค ๐ค๐ฉ๐ข๐ฏ๐จ๐ฆ?
If you canโt show which role-based permissions were active at the time, you may have a compliance issue. Once an auditor finds one attribution gap, they often look more closely at every related record. In some cases, that can affect thousands of samples.
Your system should be able to track who had which permissions, when they had them, how they were assigned, and when they changed.
If an auditor asked today, could your system show not just who made a change, but whether they were authorized to make it at that moment?
If this is a gap youโre thinking about, request a demo link in the comments below โคต๏ธ
