Dear both
Part 11 can only ever come into force in conjunction with a predicate rule (e.g. 21 CFR Part 210 is a predicate rule). You need to establish if there is a predicate rule for dietary supplements (I just don't know if there is one). If not, Part 11 will not apply.
If there is, the question remains whether you create electronic records within the meaning of Part 11 - it is best to consult the Scope and Application guidance issued by FDA.
If you are still stuck after that maybe you need to consult with an expert who looks at your specific circumstances
Regards
Siegfried
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Siegfried Schmitt
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom
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Original Message:
Sent: 12-03-2014 08:32
From: Victor Mencarelli
Subject: 21 CFR Part 11
Hi Kerry.
From my understanding, 21 CFR 11 is a "general" requirement in the regulations in terms of applicability. So if you are using electronic data as your system of record, the data really should conform to 21 CFR 11 requirements. That said, there might be ways to get around the requirement to meet 21 CFR 11 if your system is not capable or does not validate as conforming to the requirements...but that requires a lot more process than most companies want to involve in my experience. So my suggestion is to either obtain a 21 CFR 11 capable system or to remain on paper in general.
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Victor Mencarelli
Sr. Manager - Regulatory Affairs
United States
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Original Message:
Sent: 12-02-2014 09:34
From: Kerry Diaz
Subject: 21 CFR Part 11
Dear all,
We are a manufacturer of dietary suppléments. Do we have to be compliant with 21 CFR Part 11 for the management of our electronic data?
Thank you for your assistance.
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Kerry