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A Quick Guide to Responsible AI for Forward-Thinking Organizations

  • Digiform Solutions

DocuSign 21 CFR Part 11 Overview

Updated: Dec 5, 2023

DocuSign was a pioneer in the field of applying electronic signatures to electronic records and documents. Started in the early 2000s, DocuSign hit the digital scene primarily for use by the real estate and financial industries. Many people are familiar with the company DocuSign even if they haven’t already used it themselves for a transaction. DocuSign assists companies by automating the signature process, and now includes an entire suite of “Cloud Agreement” products. As Digiform has implemented DocuSign in various use cases, here is a brief overview on how their Part 11 product maintains compliance with the law.

In the late 2010s, DocuSign debuted a 21 CFR Part 11-compliant product aimed at life science companies. This product differs from DocuSign in a few ways:

  • Requires that signers create a free account in order to help identify the individual (as is required by 21 CFR Part 11 Subsection 11.100(b)). Regular DocuSign does not require an account, though one can be created for free.

  • Requires two-factor authentication (as required by 21 CFR Part 11 Subsection 11.200(a)(1)), assisted by the user having to create an account.

  • Includes a reason for signing (21 CFR Part 11 Subsection 11.50(a)(3)).

Laptop and Mobile Screen Featuring DocuSign
DocuSign Electronic Signature. Image:

While DocuSign provides a white paper and other significant documentation attesting to the product’s compliance with 21 CFR Part 11, each customer still needs to ensure that training is conducting for all end users and documented, the product is validated for its intended use, and there is someone on staff ready to review regular product updates and document and test any changes that might alter the intended use of the product. While DocuSign does offer a relatively new product called Validator for Life Sciences, companies can work to validate DocuSign on their own without the additional monthly cost of Validator. When last checked, Validator was running $1700 a month, which can be a significant cost to many companies.

DocuSign Part 11 can dramatically increase business efficiency, but can be tricky to customize and implement. We can help you plan an implementation, assist with proactive and retroactive validation, set up change control procedures, and assist with end user training. Contact Us today for a free consultation to learn how we might help.

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