Life Sciences

Who Should Notify The FDA About Using Esigs: CRO Or Sponsor?

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Several months ago we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question:

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Regarding “the organization” that needs to inform the FDA of the intended use of electronic signatures, in a CRO/Sponsor relationship, who is responsible: the CRO or the Study Sponsor? 

This question is referring to Subpart C – Electronic Signatures, Section 11.100 General Requirements, letter (c): Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

As we understand it, the organization that is ultimately responsible for the electronic records that will be signed electronically should be the one to notify the FDA. In the CRO/Sponsor situation, that would most likely be the Sponsor.

If you have any comments or follow-up questions on this topic, we’d love to hear from you. To see what other questions were asked during the webinar, click here.

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Sally Miranker

As the Head of Validation in Perficient’s life sciences practice, Sally Miranker is responsible for overseeing the Computer System Validation (CSV) methodology, System Development Life Cycle (SDLC), and all project-related validation activities. She has over 20 years of experience in the industry with almost a decade focused on implementing computer systems within regulated environments. Her knowledge and experience contribute to her ability to ensure that Perficient’s internal and client systems are implemented effectively, in compliance with internal procedures and external regulations, and following best industry practices. Prior to joining the company in 2009 via the acquisition of BioPharm Systems, Sally held a Siebel Systems Analyst position at Amylin Pharmaceuticals.

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