FDA Compliant Electronic Records - Requirements, definitions, maintenance and archive

Thread starter Douglas Cruz
Start date Nov 6, 2005

D

Douglas Cruz

Nov 6, 2005

#1

Hi
Somebody knows where can I find the document -
FDA Compliant Electronic Records: Requirements, definitions, maintenance and archiving??

Thanks in advance

Al Rosen

Leader

Super Moderator

Nov 6, 2005

#2

I did a search for that title and couldn't find anything. Do you have the name of the author or publisher? Could it be a white paper?

Miner

Forum Moderator

Leader

Admin

Nov 6, 2005

#3

Are you looking for a document with that exact title, or a standard that covers this subject matter?

If the latter, try: Title 21 Code of Federal Regulations (21 CFR Part 11)
Electronic Records; Electronic Signatures at http://www.fda.gov/ora/compliance_ref/part11/ and http://www.fda.gov/cder/guidance/5667fnl.htm

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