List of Part-11 Suppliers in the FDA Dockets

GMP News No. 216

GMP News
2 August 2002
 

List of Part-11 Suppliers in the FDA Dockets

 
It is always helpful to have an overview of suppliers of systems that comply with the requirements of FDA 21 Part 11 "Electronic Signatures and Records". Serentec has generated a list of service and software firms. However, this is no guarantee for the fact that these suppliers work in a Part-11-conform way. Please click here in order to download the supplier list.

If you want to know how FDA views the individual software products, we recommend you the Dockets on Part 11. In this section, FDA publishes all petitions and Guides connected with Part 11. You will also find meeting protocols there. Suppliers of systems that have to comply with Part 11 are given the opportunity to present their products to FDA under the leadership of Paul Motise. FDA then comments on the realised technical solutions from the aspect of Part-11. Please click here in order to read the Dockets on validation.

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

Top Conferences on Part 11
We have just finalised 2 events that explain Part-11 requirements and give real-life examples:

Author:
Oliver Schmidt
CONCEPT HEIDELBERG

PS. Did you know that FDA can even order the recall of a software program? Click  here to be shown an example.


  

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