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 theimplementation 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 bemet. Moreover, there is a need for information on how to put theserequirements into practice.

A first step towards the goal is thecompilation 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 "NationalInstitute of Standards and Technology," which is an agency of the U.S. Department of Commerce.

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

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

Here you can see the table of contents: 

Oliver Schmidt

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


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