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View Full Version : FDA Compliant Electronic Records - Requirements, definitions, maintenance and archive Douglas Cruz 6th November 2005, 02:25 PM Hi Somebody knows where can I find the document - FDA Compliant Electronic Records: Requirements, definitions, maintenance and archiving?? :confused: Thanks in advance Al Rosen 6th November 2005, 04:05 PM 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 6th November 2005, 05:51 PM 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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