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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 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:
|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.|