Electronic signatures have become increasingly important with the shift to remote work during the pandemic. 21CFR§11 provides regulations for electronic signatures and documentation in FDA-regulated industries to ensure validation and compliance. The regulations require that each electronic signature be unique to an individual and that their identity is authenticated, often with a password or pin. Software used must also maintain traceability of electronic signatures. While there are pre-validated software options, manufacturers are responsible for additionally validating software for their intended use and 21CFR§11 compliance. EMMA International offers assistance with software validation to support compliance with regulatory requirements.

1. Electronic Signatures Under 21CFR§11
By: Nikita Angane
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.
1 FDA - 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