How to apply 21 CFR Part 11 and/or cGMP in the Life Sciences industry

QUALITYTRAINER

Involved In Discussions
#1
I work as the quality engineer for a fairly small service provider with many of our customers in the Life Sciences industry. Essentially what is provided by my Company is the system (Hardware & Software) that controls and automates the flows of material through valves, actuators and other accessories. Our customers may wish to use some of our verification and validation records in order for THEM to comply with FDA verification and/or validation requirements (which do apply to them and we would therefore wish to allow them to use our records as part of their FDA compliance requirements). My question is to better understand if and how 21CFR Part 11 requirements and cGMP requirements would apply to our business. We've been recently audited by one of our Life Science customers and they have asked that we provide 21CFR Part 11 training to our employees. Does anyone have any 21CFR Part 11 and/or cGMP Training Material? Am I missing something?:bonk:
 
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yodon

Staff member
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#2
Re: How to apply Part 11 and/or cGMP

Given what you say your system does, I'm curious why they thought Part 11 even applies.

You can find the regulation here: http://www.ecfr.gov/cgi-bin/text-id...e&tpl=/ecfrbrowse/Title21/21cfr11_main_02.tpl

The scope of the regulation is:

(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations.


What records do your systems create / manage that would apply? And are those records e-signed?
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: How to apply Part 11 and/or cGMP

On top of what Don highlighted, in order to try to help you we need to understand what is the regulatory (FDA) scope that applies to your customers in general and specifically the one that audited you and posed the part 11 training request. "Life Sciences" is a broad term.

In very general terms, I'd venture saying that as an equipment supplier to regulated manufacturers, little FDA regulation (if any) applies directly to you. Supporting your customers with their compliance is a separate matter, and it's more about good business practice than about legal obligations (unless it's in a contract).

Cheers,
Ronen.
 
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