Life Sciences

Are Email Attachments Subject To 21 CFR Part 11?

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FDA-21-CFR-Part-11-Email

 

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:

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In one of the initial slides, you mentioned that documents attached to emails do not fall under 21 CFR Part 11. Could you elaborate a bit more? 

The exception appears in Subpart A – General Provisions, Section 11.1 Scope, letter (b): However, this part does not apply to paper records that are, or have been, transmitted by electronic means.

We understand this to be saying that Part 11 does not apply to any paper records, even if they are sent electronically (e.g., a scan of a paper record that is transmitted by email or fax). Now, if a file attached to an email were, say, a PDF report generated out of a 21 CFR Part 11 system, as opposed to a scanned piece of paper, the above exception would not apply.

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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