Electronic Signatures for FDA Regulated Research: Software and Systems Validated at BCM


The FDA has set forth requirements to ensure electronic records, electronic signatures, and handwritten signatures executed to electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

If your clinical trial is conducted under an IND or IDE, or the terms of your award specify that your computer systems must comply with 21 CFR 11 or similar requirements, validation documentation must be obtained for each system used to generate, collect, and store electronic records and electronic signatures. The FDA has also provided a guidance document for eSignatures. These requirements are codified as Part 11 of Title 21 in the Code of Federal Regulations, or 21 CFR Part 11, or Part 11 for shorthand.

BCM has submitted to the FDA a letter of Non-Repudiation Agreement for digital signatures to be used in lieu of and comparable to wet-ink signatures. If you need an ESG account for FDA submissions, users will be required to send a copy of the above linked BCM FDA letter.

If you are uncertain whether the requirements set forth in 21 CFR Part 11 apply to you or for assistance on how to validate a system, please contact Clinical Research at


Validated Systems/Software for use at BCM


All of the systems that have been validated require access provision and training. Please see the table below for a listing of the systems/software, the description, and who to contact for access and training.

System/Software name Description Who to Contact for Access and Training More Information or Training
Advarra eRegulatory Management System (eReg)

eRegulatory Management System is a 21 CFR Part 11-compliant system designed to adapt to clinical research regulatory workflows for any size research site and is available to clinical research teams at Baylor College of Medicine. 

eReg Support Learn more about e-reg.
DocuSign Part 11 DocuSign Part 11 is 21 CFR Part 11 and HIPAA compliant and is available for clinical research teams at Baylor College of Medicine. Senders can upload documents to an electronic envelope, add fields for signature and date, and send the envelope to a specified recipient via email.

Request DocuSign Part 11 access

DocuSign Part 11 for FDA Regulated Research Course