Life Sciences

Does 21 CFR Part 11 Apply To CTMS, CDMS, Or EMR/EHR Systems?

fda-21-cfr-part-11-ctms-edms-emr-ehr

 

On Thursday, April 23, 2015, 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:

Does 21 CFR 11 apply to a CTMS (clinical trial management system), CDMS (clinical data management system), EMR (electronic medical record), or EHR (electronic health record) system?

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The answer is basically the same for any system, regardless of the type of system. You need to consider these two factors:

  • How you intend to use the system
  • Whether paper or electronic records/signatures will be considered the official records

If the electronic records that are generated, contained, and/or approved in the system pertain to regulated activities and are going to be considered the official records (i.e., used instead of paper records), then we would say the answer is “yes.”

We suggest that you perform a GxP assessment on the system and then, if it is indeed GxP, evaluate whether it is also subject to 21 CFR Part 11. Based on the nature of a CDMS, it is most likely going to be both GxP and required to comply with Part 11.

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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