List of Part-11 Suppliers in the FDA Dockets

GMP News No. 216

GMP News
2 August 2002

Listof Part-11 Suppliers in the FDA Dockets

It is always helpful to have an overview of suppliers of systems that comply with the requirements ofFDA 21 Part 11 "Electronic Signatures and Records". Serentechas generated a list of service and software firms. However, this is noguarantee for the fact that these suppliers work in a Part-11-conform way.Please click herein order to download the supplier list.

If you want to know how FDA views theindividual software products, we recommend you the Docketson Part 11. In this section, FDA publishes all petitions and Guidesconnected with Part 11. You will also find meeting protocols there.Suppliers of systems that have to comply with Part 11 are given theopportunity to present their products to FDA under the leadership of PaulMotise. FDA then comments on the realised technical solutions from theaspect of Part-11. Please click herein order to read the Dockets on validation.

In addition to the memos on supplierpresentations, the dockets also include comments of industry groups onPart-11 Guides, like e.g. the comments of PDA/ISPE and GAMP, and ofindividual firms, as e.g. GlaxoWellcome (Dr Guy Wingate).

Oliver Schmidt

PS. Did you know that FDA can even orderthe recall of a software program? Click  hereto be shown an example.



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