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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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