GageList offers true digital signatures for FDA compliance to support the requirements of FDA’s 21 CFR Parts 11 and 820, Quality System Regulation (QSR) and ISO 13485.

The FDA requires organizations to employ means of capturing electronic signatures on electronic documents that have to be signed to verify validity. In calibration management, these include calibration certificates and other documents that validate that calibration activity was performed as required.

A powerful encrypted digital signature function and other features make GageList compliant with FDA’s 21 CFR Parts 11 and 820, Quality System Regulation (QSR), and ISO 13485.

Digital Versus Electronic Signatures

Why are digital signatures important, as opposed to simple electronic signatures? Well, they’re very different animals. While digital signatures are a form of electronic signature, not all electronic signatures are digital.

An electronic signature is a digital alternative to a “wet ink” signature (a physical signature on a paper document). It verifies the document, is legally binding and offers basic security, but it is not encrypted and doesn’t provide validation by any trusted certificate authorities or trust service providers. An electronic signature can be changed fairly easily without the knowledge of the signer.

A digital signature is a secure, encrypted electronic signature that certifies the signer’s identity as well as the validity of the document. Digital signatures are secured by trusted certificate authorities or trust service providers, are encrypted, are more secure than electronic signatures and provide more robust authentication. They cannot be altered after they are finalized.

GageList’s signature capability is a true digital signature feature, unlike some of the other calibration platforms. While it is easy to use, it offers a much higher level of security to protect your valuable calibration and quality management records.

GageList Software Validation Resources

In addition, as part of our commitment to meeting the critical quality requirements of the food, pharma and biotech industries, we offer customers a comprehensive Software Validation Kit that includes our most recent Validation Test Results, a Validation Statement, a Validation Procedure Sample and a Validation Test Template.

To learn more about how we support compliance with FDA requirements or any other regulatory standards, please reach out to our customer support team any time.