Title 21 CFR Part 11: FDA Guidance
FDA Guidance Documentation:
There was a good point brought up in a comment from a reader of this blog around the fact that the FDA had withdrawn guidance documents around Part 11 therefore they do not enforce it. There is new guidance so it can be deceiving.
You can see the withdrawn list here I am not linking to them since they are withdrawn the less that is known about them the better.:
- Guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures Validation
- Guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms
- Guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Time Stamps
- Guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records
- Compliance Policy Guide, CPG 7153.17: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures
There is new guidance which can be downloaded here : [PDF version] or read here:
This can be confusing but don’t let this fool you, the whole reasoning around the FDA withdrawing the Guidance documents was two-fold.
1 – The FDA published this guidance which is a copy (with exception of the header) of the IEEE SDLC process around hardware systems testing and validation, unfortunately software and hardware are very different and the FDA withdrew this to aliviate confustion around audits that didn’t look at any specific system with its application to the intent of the Part 11 law.
In other words, auditors are not very good at interpreting law, they took the guidance as law which had a side-effect of causing huge inefficiencies in the auditing and validation of part-11 systems.
2- Another aspect is if the government gives out advice or guidance it opens itself up for lawsuits, the government should be making laws and enforcing them, not offering guidance on following the laws.
The new guidance is a lot more vague and limited, mostly giving guidance on interpretation of the law and also aligning with any cases that have come to be known.
We are now re-examining part 11, and we anticipate initiating rulemaking to revise provisions of that regulation. To avoid unnecessary resource expenditures to comply with part 11 requirements, we are issuing this guidance to describe how we intend to exercise enforcement discretion with regard to certain part 11 requirements during the re-examination of part 11. As mentioned previously, part 11 remains in effect during this re-examination period.
As you can see part-11 is still in effect, as this would impact public safety and any efficacy of data used in clinical trials among other things.