ECA establishes new Interest Group on Pharmaceutical IT Compliance

Recommendation

22-24 May 2024
Copenhagen, Denmark

IT / OT Infrastructure Qualification and Operation in a GMP Environment

Since its foundation the ECA Foundation's mission has been to provide support to the Pharmaceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances. For that purpose the ECA has initiated and established various working and interest groups concentrating on different topics (to find out more about these groups please see the ECA Foundation website).

IT technologies as well as new regulatory requirements currently shape the IT in the pharmaceutical environment. GMP regulations can rarely follow these technologies. Thus the question in practice is quite frequently how GMP compliance requirements have to be applied in these cases. For that reason the ECA Foundation now established the new ECA IT Compliance Interest Group.

The new group is lead by an Advisory Board with seven members from industry and regulatory authorities - bringing together long-lasting experience in IT in the pharmaceutical environment. It is headed by Dr. Wolfgang Schumacher from F.Hoffmann-La Roche in Switzerland. Mission of the new group is to assemble knowledge on "burning" subjects like Cloud Computing, use of mobile devices, Data Integrity, Audit Trail review, etc.

The first project of the group is dedicated to issues around cloud computing. Under what conditions can cloud computing be used in a GMP environment? The most important prerequisite is that the cloud services provider knows the rules and constraints of the GMP regulated pharma industry. For that reason the group prepared three documents that will assist users in formulating decision criteria for selecting an appropriate cloud services provider: a best practice paper "Selection process for a Cloud Service Provider" and the two checklists "PaaS Service Providers" and "SaaS Service Providers".

The final documents are planned to be distributed to participants of the ECA event "Cloud Computing in a GxP Environment" on 10-11 March 2016 in Hamburg, Germany. The draft documents are provided on the group's new website. This website also offers a number of services for both colleagues in the pharmaceutical industry and in authorities - like latest news on IT compliance issues, Guidelines or Warning Letters related to IT compliance violations. To visit the new IT Compliance Group's website please go to www.it-compliance-group.org. There you will also find the draft documents in the members' area. For downloading and commenting you'll need to apply for membership in the new group. Membership is free of charge, though. The deadline for comments is 11 January 2016.