Part-11-Compliance CD Finished

GMP News No. 253

GMP News
25. October 2002
 

 Part-11-Compliance CD Finished

 
Upon numerous requests, we have compiled a CD-ROM containing ample important and useful information regarding the implementation of 21 CFR Part 11 "Electronic Records and Electronic Signatures."

In the pharmaceutical industry, considerable uncertainty exists as to the question which requirements have to be met. Moreover, there is a need for information on how to put these requirements into practice.

A first step towards the goal is the compilation of guidelines and interpretations on a CD-ROM. This CD-ROM contains on the one hand the most important regulations, like e.g. current Guidances for Industry and Compliance Policy Guides. On the other hand, it includes informative documents of the "National Institute of Standards and Technology," which is an agency of the U.S. Department of Commerce.

2 checklists on the CD make it possible to carry out an analysis regarding the Part-11 compliance of EDP systems. 4 articles and 3 SOPs on Part 11 give concrete advice for the implementation of the requirements.

As a last section, the "Presentations" offer the documentation of speeches held by 2 FDA representatives (Paul Motise and David Gailey Perkins) and by a representative of the pharmaceutical industry. 

Here you can see the table of contents: 

The CD will be given free of charge to the participants of the following events.

  • European Part-11 Conference, Copenhagen, Denmark
  • GMP-/FDA-compliant Raw Data Management and Archiving, Barcelona, Spain
  • We would be happy to welcome you in Copenhagen or Barcelona.

    Oliver Schmidt
    CONCEPT HEIDELBERG
       

    PS. Here we would like to express our thanks to Dr Ludwig Huber and Dr Wolfgang Schumacher, both members of the ECA Advisory Board, for their support.
      

    Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

    OK

    Go back

    GMP Conferences by Topics

    Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

    OK