Workshop at the 22nd A3P Congress: Classify your IS-IT systems according 21 CFR part 11

Nathalie Romanet-Robineau, Recipharm  Moderator of the workshop

Workshop N°9 organised at the 22nd A3P Congress, October 20th, 21st and 22nd, 2009

IS/IT systems are found everywhere and are now 100% part of our routine operations. It is currently usefull and efficient but could also be an issue when we are talking about qualification and validation.

Introduction of the workshop will be done as a lecture to remind regulatory requirements and most current definitions.

 

The team will be then splited in 2 groups working on establishing a check list to categorise the systems.

Check lists will be shared with all the team and a reference list will be agreed. This check list will develop questions we have to answer in order to classify the systems according GXP requirements.

 

The target of the second part of the workshop, again in two groups, will be to write the qualification master plan for one system given as an example according the previous agreed question list. The groups will be coordinated by Olivier Corriger and Nathalie Robineau from Recipharm Monts.