Hardly another regulation is currentlyattracting as much attention in the pharmaceutical industry as is 21CFR Part 11. In the following we have compiled some important websources so as to provide you with a profound insight into therequirements and their implementation.
21 CFR Part 11 is so important to FDA that it has been given itsownsection of the web site.There you will find 2 core documents for GMP-conform implementation
- Federal Register
- Compliance Policy Guide
The interpretation of the requirements poses a considerableproblem. In order to be able to answer the most frequently askedquestions we recommendhttp://www.fcg.com/webfiles/WhitePaper/white_paper_files/wp21CFRpart11.aspand http://www.labcompliance.com/index.htm.The "Frequently Asked Questions" are a good place to startinto the material.
In Europe we have no equivalent regulations at present, althoughhttp://www.bmck.com/ecommerce/eu.htmlists a whole series of documents of intersectoral relevance. FDAwill therefore publish further-reaching Guidance Documents. In orderto do this, minutes of meetings and industrial commentaries arecollected in dockets http://www.fda.gov/ora/compliance_ref/part11/dockets_index.htm.Topics for Guidance Development are:
- Audit Trail
- Electronic Copies for FDA
- Time Stamps
In these dockets you will find interesting minutes of meetings,e.g. the presentation of various software programs by theirsuppliers and the FDA comments on the software. This is certain tobe of interest to anyone wishing to acquire a '21 CFR Part11'-conform system.
Athttp://www.fda.gov/ohrms/dockets/dockets/00d1543/lst0001.pdfyou will find in the dockets a glossary which explains the mostimportant terms connected with 21 CFR Part 11. At http://www.fda.gov/ohrms/dockets/dockets/00d1541/mm00014_01.pdfyou will find an interesting discussion of May 30, 2001 on the topicof "When does the Audit Trail begin?". This topic willcertainly be specified by FDA in future Guides. The IndustryCoalition describes how implementation can take place in itstwo-page paper http://www.fda.gov/ohrms/dockets/dockets/00d1541/mm00014_02.pdf
The importance of 21 CFR Part 11 as a topic is underscored by thefact that it has its own web site (www.21CFRPart11.com). It containsrevealing information for all interested persons. We can surelyrecommend taking a look at the FDA Warning Letters on this topic;you will find them athttp://www.21cfrpart11.com/fda_docs_warning_letters.htm.
The interest groups PDA and ISPE/GAMP are currently elaboratinginterpretations of Electronic Records and Electronic Signatures. Youwill find the Final Draft of the new GAMP Guide to this topic athttp://www.21cfrpart11.com/library/government/gamp_final_draft_eres.pdf.It's worthwhile reading for all those planning the implementation of21 CFR Part 11.
We hope that this list is a help to you. If you have anyquestions on Electronic Records and Electronic Signatures you canask them in the discussion forum of the European Compliance Academy.The moderators are the two Advisory Board members Dr. Ludwig Huberand Dr. Wolfgang Schumacher.
Author:Oliver Schmidt, CONCEPT HEIDELBERG