Dr. Barbara Schnurr,
Managing Director,
GXP Engaged Auditing Services

HCR launches company GXP Engaged Auditing Services

www.gxp-engaged.com

GXP Engaged Auditing Services has been launched as a limited company by the Harrison Clinical Research Group (HCR). GXP Engaged Auditing Services will complement and strengthen the well established and experienced audit department of HCR. Audit services cover all functional areas of client clinical studies, including critical suppliers and investigational sites, key activities like for instance project management, clinical monitoring, regulatory affairs, safety, data management and biometrics and auditing essential documents such as protocols, patient information and informed consent documents, tables and listings and clinical study reports, as well as Trial Master Files and Investigator Files.

After implementation of the Directive 2001/20/EC and as specified in article 16 of Common Directive 2005/28/EC, Quality Control and Quality Assurance are a legal requirement for sponsors. Sponsors sub-contract to the independent group audits, which follow the applicable standards of ISO 9011 and the ENGAGE Optional guideline for GCP compliance and Quality Systems Auditing, from the European Network of GCP auditors and other GCP experts. These stipulate that all audits are conducted according to the auditing plan, which is formally released upon mutual agreement with the sponsor. Audit reports are written within defined timeframes, peer reviewed and released from the lead auditor and sponsor's representative. A formal signed documentation, confirming that all findings have been addressed, is always considered as part of the audit results.

In addition to full audit services, GXP Engaged Audit Services offer help in revising and/or setting up and implementing QM systems in client offices and in the preparation and conduct of system audits. This type of service has been can be provided for small, mid-size and large companies in pharmaceutical, biotechnology, medical device, nutritional science and related industries. Also, services related to inspection preparation, including mock inspections and the provision of support during inspections are possible.

Dr. Barbara Schnurr, Managing Director of GXP Engaged Auditing Services, said at the recent launching, "We are excited to be able to launch this company as an extension of the long established, tried and tested auditing services of Harrison Clinical Research, which has been ISO 9001 certified since 1998 and recently received the Gold award from Lloyd's Register Quality Assurance, for 10 years of certified compliance with ISO 9001 standards. GXP Engaged Auditing Services is an independent company and the confidentiality of audit findings is absolutely guaranteed. Our services have been adapted by our auditors to suit the needs of contracts from all types of client company. Depending on the scope, language requirements and complexity of the programme, audits are often performed in teams together with co-auditors from the sponsor.

Our auditing team has gained vast experience auditing all studies carried out by HCR since 1996, as required by our QM system. This means that over 600 studies have been audited in Germany, USA, Slovakia, Poland, Romania, Austria, Netherlands, Czech republic, Bulgaria, France, Israel, Russia, Italy, India, Slovenia, Estonia, Belgium, UK, Croatia, Latvia, Spain, Hungary, Lithuania. We are looking forward to continuing interaction between Europe, USA and overseas whether it be pertinent to GCP, GLP or GMP, support for FDA or EMEA inspections, audits of study documents, clinical study reports, protocols, dossiers or validation audits 21 CFR Part II or other standards."

Dr. Francisco Harrison, Chairman of the Harrison Clinical Research Group, went on to say, "Although GXP Engaged Auditing Services is a fully independent company, it will respond with the same Quality Management as HCR in fulfilling customer's needs, with the goal to strive for continuous improvement in the management of project resources, to promote a consistent quality level in the interaction between sponsor management, investigational staff and suppliers".

Dr. Schnurr added, "We are pleased to have the backing of the HCR Group which gives us a tremendous opportunity to demonstrate and promote our services worldwide."

ContactBarbara Schnurr,
GXP Engaged Auditing Services