Electronic Signatures Under 21CFR§11

by | May 17, 2021 | CFR, Digital Health, FDA, Guidance, Regulatory

In the work from home era, we all realized how important it is to digitize our important documents and what a lifesaver digital signatures are. With everything now getting electronically stored, electronic signatures and documentation are slowly replacing the paper-based system. That means we must now get ready to expand our digital storage plans rather than buying new filing cabinets.

Companies who shifted to remote work had to inevitably adapt to the electronic signature world. Electronic signatures are easy to use however, the big looming question is the validation that it requires for the FDA-regulated industries. 21CFR part 11 is the gold standard to ensure that electronic signatures and software that helps in applying these signatures have been validated and are compliant

Part 11 requires that each signature be unique to the individual signing and also that the identity of the individual be authenticated. Thus, the regulations mandate that the software system requires the individual to enter a password or a pin before being able to sign off electronically. The regulations also require that the authentication system used in the software must have an identification code for the individual to ensure that traceability is maintained throughout.1

There are off-the-shelf software systems that will assure that the system has been validated and has been developed in compliance with 21CFR§11, however, as a manufacturer, regulations require that you validate the system to its intended use in addition to 21CFR part 11 compliance.

Non-product software validation requires the development of appropriate requirements, use cases, test steps and can be overwhelming for individuals who have not dealt with software applications before.

EMMA International can assist in all your validation needs whether you require additional support for your team in doing validations or need a particular software validation done. Call us today at 248-987-4497 or email us at info@emmainternational.com to learn more about how we can help.


1FDA – PART 11    ELECTRONIC RECORDS; ELECTRONIC SIGNATURES retrieved on 05/13/2021 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1&subpartNode=21:1.0.1.1.8.3

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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