Computerised Systems

The PIC/S Expert Circle on Computerised Systems was established in 2002. It has been active in the training of Inspectors in the inspection of Computerised Systems for GXP inspections. The Expert Circle has also developed the PIC/S Guidance on Good Practices for Computerised Systems in Regulated GXP Environments (PI 011), currently under revision.

Chairperson of PIC/S Expert Circle on Computerised Systems, Karl-Heinz Menges (Germany / ZLG)

Key Features

In 2015, the PIC/S Expert Circle on Computerised Systems was turned into a Working Group in order to focus on the revision of the PIC/S Guidance on Good Practices for Computerised Systems in Regulated GXP Environments (PI 011). Working Group members are also involved in the PIC/S Working Group on Data Integrity and are monitoring developments in the field of Computerised Systems as well as addressing future challenges posed by “novel”  technologies. The aim of the revision is to ensure that PI 011 and Annex 11 are kept up to date and harmonised with other documents widely used by industry.

Guidance Document

A number of guidance documents developed by the PIC/S Expert Circle on Computerised Systems are publicly available under  "Publications".

Past Expert Circle Meetings

Vienna | Austria 2012
Melbourne | Australia 2009
Dublin | Ireland 2007
Düsseldorf | Germany 2006
Utrecht | Netherlands 2005
Bern | Switzerland 2004
Camberra | Australia 2003
London | United Kingdom 2002

 

Upcoming Expert Circle Meetings

There are no upcoming Expert Circle Meetings scheduled while the Expert Circle remains a Working Group. The Working Group is only open to Members of the Working Group nominated by PIC/S Participating Authorities.

Training Materials

Expert Circle training meeting materials are available under MaterialsLogin is required.