Medical Devices Data Verification

GOOD DOCUMENTATION PRACTICE (GDocP)
1

I was wondering which data required another persons verification? what is the criteria?

2

Anything that supports a product release.

What stage of the lifecycle are you in? Investigative (feasibility or pre-development), R&D, clinical, or commercial release?

Are you in the clinic, lab, manufacturing, engineering?

3

Thanks for your answer… I am in manufacturing.

4

Without knowing the specifics of your process or what in manufacturing you are doing - in my experience pretty much every single step of the manufacturing process is signed, and counter signed by another person. There is a “performed by” and a “verified by” or “witnessed by” signature.

Is it a pain? Yes it is. It is part of the Good Documentation Practices (GDP) common practices. Does the FDA require it to be done verbatim? I’m not sure. It might not be in the law, but in practice I really think a QA department would err on the side of safety and not risk an FDA audit finding for this thing.

Also data integrity is a HUGE concern for the FDA and other agencies. Many companies have gotten into pretty big warning letters for failure to control data, and counter signature is one means to ensure data is valid and is integrous.

So I think that the likely answer is yes, counter-signature is required. Your specific application might be different, though (like sending an email doesn’t require a second signature, for example).

5

Hi Guys,

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We have rolled this course out globally to a number of top pharma companies.

Thank you

6

I will definitely take a look. Thanks!!!

7

Thanks a lot. It makes sense. Is better to err on the safe side. Will check out the course.