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ISO 13485 and compliance of electronic signature

#1
Hi All,

Company I currently work for is thinking to introduce the electronic signatures as a part of objective for 14001-company is also certified to 13485.
Electronic signatures will be used to sign of variety of different documents- from customer specific medical devices validation protocols to internal procedures. majority of employees use Terta that comes with Adobe acrobat pro.
Is the a reason to worry about security of electronic signatures from regulator perspective?
And is there anything I have to do before being able to introduce electronic signature?
Help to understand the topic would be greatly appreciated:)
 
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Gisly

Starting to get Involved
#2
Hi
Not sure where you are based and what your markets are but for US you should look at CFR part 11 and at the European eSign regulations (Part 11 should cover you though). To my knowledge the ISO13485 does not set forth any requirements to the integrity of signatures.
 
#3
Hi
Not sure where you are based and what your markets are but for US you should look at CFR part 11 and at the European eSign regulations (Part 11 should cover you though). To my knowledge the ISO13485 does not set forth any requirements to the integrity of signatures.
I'm based in UK and although we do not have to comply to mentioned above sometimes customers need to comply with it.
 

yodon

Staff member
Super Moderator
#5
Is the a reason to worry about security of electronic signatures from regulator perspective?
Setting aside the regulatory concern for a bit, recognize that the electronic signature is as legally binding as a "wet ink" signature. You want to be sure the electronic signature has the same integrity as a wet ink signature. There are some good points in 21 CFR 11 about protecting the signature, ensuring the meaning of the signature is understood, etc. So from strictly a business perspective, you want to be sure electronic signatures are properly managed.

Back to the regulatory question. If an auditor asks to see an electronically signed document, then asks for proof that the signature is authentic, how would you respond? I've seen places where they digitally captured a signature (i.e., jpg) and pasted it into a document and called it signed. No protections so anyone could have pasted it in. I've seen other places where a manager gave his assistant his credentials to apply an electronic signature. The point is that while wet ink signatures can be forged, there are even more ways that you can lose control with electronic signatures.
 

Ajit Basrur

Staff member
Admin
#6
Hi All,

Company I currently work for is thinking to introduce the electronic signatures as a part of objective for 14001-company is also certified to 13485.
Electronic signatures will be used to sign of variety of different documents- from customer specific medical devices validation protocols to internal procedures. majority of employees use Terta that comes with Adobe acrobat pro.
Is the a reason to worry about security of electronic signatures from regulator perspective?
And is there anything I have to do before being able to introduce electronic signature?
Help to understand the topic would be greatly appreciated:)
Adobe Acrobat Pro DC comes with lot of compliance - few tweaks may be required but is pretty good.

Disclaimer: I am just an user of Adobe Acrobat Pro DC
 
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