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Books and booklets

Was sollte ein GCP-Auditor wissen und können? (What should a GCP-Auditor know and be able to do?)

Experience shows that the success of an audit depends largely on the qualifications of the auditor. This includes not only technical expertise but also social competency and communication skills. This german-language brochure presents the essentials from an 80-page manuscript detailing the most important factors influencing Auditor training and professional development. GQMA-Members can download the brochure from the members-only section of the web-site; others may request a free copy from the President of the society: Steffen König, IST GmbH, Soldnerstrasse 1, 68219 Mannheim.


Audits in GCP and Beyond
3rd, revised and enlarged edition (2015) of a multi-author hand-book prepared by an Expert Group of the DGGF. The book (ISBN 978-3-87193-410-0) can be purchased from the ECV Publishing Company. For more information look in the Flyer.

Digitalisierung von Dokumenten in einem GxP-regulireten Umfeld / Digitalization of Documents in a GxP-regulated Environment.

It is becoming increasingly common for test facilities to digitalise paper raw-data and other records and store these data in electronic archives. The GQMA Working Parties for Archiving and for Information Technology have prepared a brochure (available in German and English) which discusses the regulatory framework for such work and then provides detailed, practical advice on the organizational and technical requirements to be fulfilled. GQMA-Members can download the brochure from the members-only section of the web-site.

The second revised edition of the brochure is available in German and English. For members, the brochure is available for download in the new members area.
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