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Validation of a PDMLink installation to CFR21 part 11 requirements

Newbie

Validation of a PDMLink installation to CFR21 part 11 requirements

Hi there,

Has anyone come accross PTC documents that would help with validating a PDMLink with Creo installation, to show that the system complies with the requirements of the FDA's CFR 21 part 11?

These regulations deal with the security of electronic signatures.

Useful documents would be a User Requirement Specification, Functional Specification, Installation Qualification, Operational Qualification and Performance Qualification.

If there is another company that has created these documents and would be willing to let other's use them that would be interesting too.

Thank you for any help anyone can give.

Best regards,

Paul Goodwin.