About the IT Compliance Group


The GxP compliance of Informatics and their services provided for the business is an intensively discussed subject. The fast growing computer technologies are providing headache to both Regulators and the Pharmaceutical Industry on how to meet compliance requirements. The GxP regulations cannot be developed with the same speed as new technologies evolve and are furthermore not providing the detailed guidance needed by the Subject Matter experts. Therefore there are continually discussions internally and during inspections with regard to issues like Cloud Computing, use of Mobile Devices, Data Integrity, Audit Trail Review and SLAs.

For that reason, the “IT Compliance” Working Group was founded by the ECA Foundation.

Mission of the group is to assemble knowledge on “burning” subjects, like those mentioned above. It is our aim developing best practice guides to help the industry to solve issues in a comprehensive and compliant manner. The group took advantage of the experience and knowledge of its members and the learnings from previous courses and conferences to contribute to the development of a number of papers.

The group’s first project deals with cloud computing. How can economic pressure for introducing cloud computing and potential GMP concerns be brought together? The group will develop a SOP to support you in choosing a cloud service provider. As member of the group you can download and comment the first draft of this SOP.

Board of Directors:

Dr Wolfgang Schumacher (F. Hoffmann-La Roche Ltd) Chairman
Frank Behnisch, CSL Behring GmbH, Marburg
Dr Andreas Mangel, Concept Heidelberg GmbH
Dr Bob McDowall, R.D., McDowall Ltd Dr Bob McDowall, R.D., McDowall Ltd
Yves Samson, Kereon AG, Basel
Michael Wegmann, F. Hoffmann-La-Roche Ltd, Basel

Authority Advisory Board

The Authority Advisory Board is not part of the legal structure. The Advisory Board Members support the IT Compliance Group on a case by case decision and not for all of its activities. The following Board Members of the ECA Foundation Board support the IT Compliance Group:

Karl-Heinz Menges, Regierungspräsidium Darmstadt Karl-Heinz Menges, Regierungspräsidium Darmstadt

Please find here all Members of the Authority Board of the ECA Foundation.

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