21 CFR Part 11- What about handwritten signatures?

C

CTea

Registered
#1
#1
My company is in the midst of validating an eQMS software. As I'm sure many of you know, this is quite the process, and it's being accomplished module by module. We have two locations, and there are things like engineering V&V plans and reports - as well as other documents- that are reviewed and signed off by persons in both facilities. I've been looking into the possibility of putting Adobe Sign (or some other part 11 complaint e-signature utility) in place to make it easier to get these signatures on these sorts of documents in the most expeditious way possible.

My question is- if we validate an e-signature utility, are we committing to having only e-signatures on every record for our company, or just establishing that e-signatures are equivalent to handwritten ones. Though I would prefer to transition to nearly paperless, I suspect that handwritten signatures would still occur on occasion, and I don't want to put us out of compliance if that should happen.

I appreciate any input/ thoughts.
 
GAGEpack - Gage & Calibration Management
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chris1price

chris1price

Trusted Information Resource
#2
#2
Providing your procedures are written to allow for both electronic and/or handwritten signatures, everything still meets part 11 and you validate all eventualities, then I can't see any problems.
 
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