Hello,
we are manufacturing Data loggers that are integrated with a Comprehensive dashboard system to retrieve, store data from any machines through PLC. A Pharma company insists for 21CFR compliance for data integrity and digital signatures while implementing my system for them. Should we approach any agency to get this 21CFR compliance for my software system?
Please guide me [email protected]
Regards
Infant
Hello, and welcome.
CFR21 part 11 is a regulatory requirement for all pharmaceutical industries regulated by FDA, if you are not sure your equipment complies with it, I think you could hire consultant services to aid you in this endeavour.
You can either provide (sell) your client robust documentation that serves as documented evidence of CFR21 part 11 compliance (so that your client does not have to do the tests themselves), or you could just provide them the technical information they require to ensure that they will be buying compliant equipment, like technical sheets, operation manuals, design specifications, etc.