Help with Electronic Records and Electronic Signatures

GMP News Nr. 132


GMP News
13 September 2001


Help with Electronic Records and Electronic Signatures 

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
  • Federal Register
  • 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 and The "Frequently Asked Questions" are a good place to start into the material.

    In Europe we have no equivalent regulations at present, although 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 Topics for Guidance Development are:
  • Archiving
  • Audit Trail
  • Electronic Copies for FDA
  • Glossary
  • Time Stamps
  • Validation
  • 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 11'-conform system.

    At you will find in the dockets a glossary which explains the most important terms connected with 21 CFR Part 11. At 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

    The importance of 21 CFR Part 11 as a topic is underscored by the fact that it has its own web site ( 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

    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 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

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