Services
Quality Assurance and Auditing
Quality management for you
Our auditing team is part of the Quality Management Group and has gained a vast amount of experience by conducting audits for over 500 studies in more than 20 countries, since 1996. We provide a full range of services, including the preparation, conduct, documentation and follow-up and certification of site and system audits. Audits can also be performed in teams together with co-auditors from the Sponsor.
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
We can audit, in compliance with your SOPs or our own:
- Study sites and facilities
- Sub-contractors
- Study protocols
- Patient information/patient informed consent forms
- Case report forms
- Trial master files
- Data management
- Clinical reports
Audit documentation includes:
- A peer reviewed audit plan
- A project specific audit SOP for more complex audits
- Tailored worksheets
- Communication of audit findings/follow-up plan
- Statistical evaluations on audit findings to prioritise preventative actions
- Audit certificates
Our auditors have broad range experience as well as having audit experience regarding:
- Analytical and clinical laboratories
- Phase I units
- Medical device studies
- Data management
- Electronic data capture
- Qualification records/training documents
Feel free to phone us
... straight away and we will work out together a tailor made solution for you.
Tel: (49) - 89 - 126680-0
Flyer to download
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