Hardly another regulation is currently
attracting as much attention in the pharmaceutical industry as is 21
CFR Part 11. In the following we have compiled some important web
sources so as to provide you with a profound insight into the
requirements and their implementation.
21 CFR Part 11 is so important to FDA that it has been given its own
section of the web site.
There you will find 2 core documents for GMP-conform implementation
Compliance Policy Guide
The interpretation of the requirements poses a considerable
problem. In order to be able to answer the most frequently asked
questions we recommend http://www.fcg.com/webfiles/WhitePaper/white_paper_files/wp21CFRpart11.asp
The "Frequently Asked Questions" are a good place to start
into the material.
In Europe we have no equivalent regulations at present, although http://www.bmck.com/ecommerce/eu.htm
lists a whole series of documents of intersectoral relevance. FDA
will therefore publish further-reaching Guidance Documents. In order
to do this, minutes of meetings and industrial commentaries are
collected in dockets http://www.fda.gov/ora/compliance_ref/part11/dockets_index.htm.
Topics for Guidance Development are:
Electronic Copies for FDA
In these dockets you will find interesting minutes of meetings,
e.g. the presentation of various software programs by their
suppliers and the FDA comments on the software. This is certain to
be of interest to anyone wishing to acquire a '21 CFR Part
you will find in the dockets a glossary which explains the most
important terms connected with 21 CFR Part 11. At http://www.fda.gov/ohrms/dockets/dockets/00d1541/mm00014_01.pdf
you will find an interesting discussion of May 30, 2001 on the topic
of "When does the Audit Trail begin?". This topic will
certainly be specified by FDA in future Guides. The Industry
Coalition describes how implementation can take place in its
two-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 the
fact that it has its own web site (www.21CFRPart11.com). It contains
revealing information for all interested persons. We can surely
recommend taking a look at the FDA Warning Letters on this topic;
you will find them at http://www.21cfrpart11.com/fda_docs_warning_letters.htm.
The interest groups PDA and ISPE/GAMP are currently elaborating
interpretations of Electronic Records and Electronic Signatures. You
will find the Final Draft of the new GAMP Guide to this topic at http://www.21cfrpart11.com/library/government/gamp_final_draft_eres.pdf.
It's worthwhile reading for all those planning the implementation of
21 CFR Part 11.
We hope that this list is a help to you. If you have any
questions on Electronic Records and Electronic Signatures you can
ask them in the discussion forum of the European Compliance Academy.
The moderators are the two Advisory Board members Dr. Ludwig Huber
and Dr. Wolfgang Schumacher. Click here.
Our other recommendation on this topic:
- For all those who would like an overview of the current
requirements and the implementation on the basis of selected
examples we recommend the Electronic
Documentation Conference on November
29/30 in Hamburg
Oliver Schmidt, CONCEPT HEIDELBERG