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 clinicalresearch@bcm.edu.

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.