GXP Engaged Auditing Services Relaunched As Independent QM Consultancy And QA And Auditing Services Company
The relaunch of GXP Engaged Auditing Services as an independent company enables it to work with those companies such as CROs, pharmaceutical, biotechnology, medical device or public companies or regulatory or QM service providers, who could not or would not work with the company before.
- (1888PressRelease) April 26, 2011 - GXP Engaged Auditing Services, the global QM Consultancy and Audit Services company, with headquarters in Munich, Germany, has been created as a management buy-out company of the auditing and consultancy service brand of the ISO 9001 certified Harrison Clinical Research Group. GXP Engaged Auditing Services will provide assistance for the industry which requires full independence from other service providers involved in clinical research. The QM team involved in the execution of GXP Engaged Auditing Services contracts has provided this type of service for companies in the pharmaceutical, biotechnology, medical device, nutrition and related industries, since 2003.
The significant increase of auditing business, the extension of trial specific QM support towards more ongoing compliance oversight, and the involvement of GXP-Engaged Auditing Services in evaluation and development of QM system support of sponsors require adequate resources and independence from other service providers. With the management buy-out strategy these objectives were achieved.
GXP Engaged Auditing Services can be of assistance to:
• Clinical Research Organisations (CROs)
• Any company from the pharmaceutical, biotechnology, medical device, nutrition or related areas with QM support requirements for clinical trials or company systems and procedures
• Public companies
• Regulatory or QM service providers who need resources in this field
The most critical deliverable of the performance of GXP Engaged Auditing Services is the quality and experience of its network of QM professionals and the very specific experience they have, located in the geographical area of the auditee and/or client. Great care is taken in the selection of our contract staff, with documented tools and processes used to ensure high standards.
Core Services:
• Revising and/or setting up and implementing QM systems in client companies, including writing or support with writing SOPs
• Independent full or partial Quality Management or Quality Assurance coverage of client companies who need additional resources in QM/QA
• Definition and/or execution of Quality Management and Auditing plans for clinical trials conducted by companies who need or wish to have a strong local oversight of their clinical trials in participating countries
• Preparation of and participation in audits and due diligences at client companies
• Conduct of audits for clients covering all areas of clinical studies
We have several Service Packages that can also be tailored to your individual needs.
Speaking on the occasion of the relaunch, Managing Director, Dr. Barbara Schnurr, said, "We are very happy to have taken this step towards total independence as it will be of definite advantage to GXP Auditing Services in attracting new clients or those clients who could not work with us before. We have been operational since 2003 and have a large experience database working in 27 countries. GXP Engaged Auditing Services works in accordance with all usual regulatory standards both local national and international, including GCP, GLP, GMP, ISO standards and those of the FDA, EMA and WHO."
Dr. Barbara Schnurr has held senior management positions in Quality Management for the last 15 years. She is well known and has a respected public reputation from her exposure to many client companies, multiple publications and presentations at international congresses. She is a member of BARQA (British Association for Research Quality Assurance) and holds the EOQ certificate as Quality Manager and the DGQ certificate as internal auditor. Her work has been successfully audited by the FDA and other national regulatory bodies as well as many clients and she has helped several client companies achieve ISO 9011 certification.
Do give Dr. Barbara Schnurr, Managing Director, a call on ++49 (0)89 126680-82000, or e-mail her info ( @ ) GXP-Engaged dot com or contact us via http://www.gxp-engaged.com to discuss how GXP-Engaged Auditing Services can be of help to you.
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