GXP Engaged Auditing Services, with headquarters in Munich, Germany, provides QM Auditing and Consultancy services worldwide. These services are rendered through our global network of independent and highly qualified, QM resources, with extensive operational experience in delivering our services to small, mid-size and large companies in the pharmaceutical, biotechnology, medical device, nutrition and related industries, as well as to authorities and academia. In this way we guarantee full independence from other service providers involved in clinical research.
Responding to an ever growing Quality Management market is driven by increased requirements from regulatory authorities and a general trend towards outsourcing very specific, highly specialised activities.
The key to the performance of GXP Engaged Auditing Services lies in the quality and experience of our QM professionals. All of our auditors have at least 5 years’ experience in auditing. Most are professionals with whom we have worked for many years; others have gone through our stringent qualification and onboarding process. QM consultancy activities are usually single activities which require very specific experience and, ideally, a professional who is located and/or well-versed in the geographical area of the auditee and/or sponsor. We take great care in the selection of our staff and have documented tools and processes used to ensure high standards.
Managing Director, Dr. Barbara Heumann, is an established QM professional with over 25 years of working experience in QM and Auditing. Her reputation has been strengthened through multiple publications and presentations at national and international conferences.
Dr. Heumann is a member of RQA (Research Quality Association), GQMA (German Quality Management Association) and she has the EOQ certificate as Quality Manager and the DGQ certificate as internal auditor.
As Managing Director, Barbara’s primary focus is the interaction between all Sponsors in all countries. Her goal is to fulfil customer needs and promote a consistent quality structure between sponsor management, investigational staff and suppliers worldwide.