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I am looking for a Digital Signature solution that will satisfy the FDA’s 21 CFR Part 11 regulation.
I am developing a QMS for compliance to ISO 13485.
I intend to write my SOPs in word convert to PDF and then get a number of staff to use Adobe Acrobat Standard to digitally sign. However my understanding is that this alone will not satisfy 21CFR part 11. In order to acheive this I need to either purchase a 'black box' which will internally in the organsiation encrypt signatures and provide additional security (high cost 20K$) or use PKI public key infracstructure digital certification via a 3rd part eg Verisign also a costly solution.
Is there a simpler solution.
Regards
Dylan snow
I am developing a QMS for compliance to ISO 13485.
I intend to write my SOPs in word convert to PDF and then get a number of staff to use Adobe Acrobat Standard to digitally sign. However my understanding is that this alone will not satisfy 21CFR part 11. In order to acheive this I need to either purchase a 'black box' which will internally in the organsiation encrypt signatures and provide additional security (high cost 20K$) or use PKI public key infracstructure digital certification via a 3rd part eg Verisign also a costly solution.
Is there a simpler solution.
Regards
Dylan snow