GMP News No. 253
25. October 2002
Part-11-Compliance CD Finished
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.
We would be happy to welcome you in Copenhagen or Barcelona.
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.