17/18 June 2021
GMP News No. 216
2 August 2002
Listof Part-11 Suppliers in the FDA Dockets
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).
PS. Did you know that FDA can even orderthe recall of a software program? Click hereto be shown an example.