Document Review And Sign Off Second Person Review - FDA Requirements

[theGrod]

I am searching ISO-13485 7.5. and 21CFR820.70 to find where it is required that ALL manufacturing process documents such as batch records and inspection sheets need to be signed by the operator and a second party reviewer (eg: QA). Our Consultant says it is an FDA requirement. Our final release is second person reviewed and some other sheets in a complex process but are ALL of them required to be second person reviewed.

 

[kacody]

I believe what you are looking for is in 820.80 (d), where it talks about the entire package being reviewed and approved prior to device release.

 

[Mark Meer]

There is nowhere (as far as I know) in the 21 CFR 820 regulations explicitly requiring a second signature on any records.

In practice (depending on your system), I'd suggest the following:

- Records of in-process acceptance/testing activities are signed and dated by the individual(s) carrying them out.

- Final testing/inspection (prior to release) are signed and dated by the individual(s) carrying them out.

- Final release authorization is signed and dated by a designated person (e.g. QA), which includes reviewing all the above documentation.

 

[theGrod]

Thank You! That is exactly the way I read the requirements.

 

[LiamD]

@MarkMeer

Can you explain in which section of 21 CFR 820 does it state that the following are needed:-

- Records of in-process acceptance/testing activities are signed and dated by the individual(s) carrying them out.

- Final testing/inspection (prior to release) are signed and dated by the individual(s) carrying them out.

- Final release authorization is signed and dated by a designated person (e.g. QA), which includes reviewing all the above documentation.

We are perform medical device verification performed by multiple people. We are having an internal discussion as to the level of sign off that is necessary. We intend to have a document sign off by all testers, then it will be passed to QA for signature.

Do we really need every individual test signed and dated as tests are performed?

 

[joylc]

- Records of in-process acceptance/testing activities are signed and dated by the individual(s) carrying them out. 820.80 e 2 & 4

- Final testing/inspection (prior to release) are signed and dated by the individual(s) carrying them out. 820.80 e 2 & 4

- Final release authorization is signed and dated by a designated person (e.g. QA), which includes reviewing all the above documentation. 820.80 d 3

See section numbers in red