Services
Quality Assurance and Auditing
Quality management for you
Our Quality Management team involved in study specific QA activities is fully independent of operational tasks and, therefore, meets all requirements specified in, for example, standards like ENGAGE or ISO 19011.
Quality Management responsibilities include all planned and systematic evaluations necessary to ensure that all quality requirements are fulfilled and that a study is conducted in compliance with applicable standards. The evaluations can be study specific or non-study specific and include self-inspections in the GMP relevant areas.
The internal quality system at Harrison Clinical Research is an ongoing programme to ensure that all studies are ICH/GCP and GMP compliant and follow applicable Standard Operating Procedures (SOPs), or Quality System Procedures (QSPs). The Quality Management department issues a Quality Management Plan for each new study.
Our Quality Management Group can assist you in managing your quality management systems, by:
- Reviewing current structure and policies, processes and documentation
- Establishing a comprehensive and efficient system enabling a consistent quality structure
- Identifying and initiating corrective and preventative actions to continually improve your processes
- Assistance in writing, reviewing, updating and adapting standard operating procedures (SOPs) to your specific needs and minimum requirements
- Training auditors and quality managers
- Preparation of training plans and documentation for training
Audits, in compliance with your SOPs or ours, are carried out by the independent management buy-out company GXP Engaged Auditing Services:
- Over 600 audits have been carried out in 27 countries
- Audits cover critical suppliers and investigational sites
- Key activities, like project management, clinical monitoring, regulatory affairs, safety, data management and biometrics
- Essential documents, such as protocols, patient information and informed consent documents, tables and listings, clinical study reports, trial master files and investigator files
- Help is also given in revising and/or setting up and implementing Quality Management systems in client offices and in the preparation and conduct of system audits
For further details, see
www.GXP-Engaged.com
Feel free to phone us
...straight away and we will work out together a tailor made solution for you.
Tel: (49) - 89 - 126680-0
Monika Mayerhöfer,
Director Quality Management
Flyer to download
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Videos
Gold Award to
Harrison Clinical Research
Presentation to HCR, by Lloyd's Register Quality Assurance (LRQA) of the Gold Award for more than 10 years of certified compliance with ISO 9001 standards.