With over 12 years of practical GCP auditing experience in more than 140 audits from Phase I – IV, Closed Loop Quality Ltd is able to plan for success to achieve high quality audit results.
With prior experience of managing outsourced personnel, the need for a transparent and proactive audit process is well understood, so clients can rest assured knowing their audits are in capable hands.
Geographical Coverage:
Closed Loop Quality Ltd. has a wide and varied portfolio of experience, with audits having been performed in the following geographical regions:
- Eastern/Western Europe
- United States of America
- South America (Argentina)
- Africa (South Africa)
- Asia (India)
We actively welcome audits in new locations or countries, and continuously seek to expand our ability to perform international audits.
Audit Types:
Closed Loop Quality Ltd. has a wealth of experience in the following audit types and subject areas:
- Site Audits (Including for-cause/directed audits and inspection readiness visits)
- Systems Audits (Regional/local office audits and global systems audits focusing on processes such as project management / clinical operations / Trial Master File (TMF) / electronic Case Report Form (eCRF) procedures, and Clinical Study Report (CSR) generation)
- Vendor Audits (CRO/ARO services such as project management, clinical operations, risk-based monitoring, quality assurance and quality control, out-of-hours safety contact and medical devices)
For more information as to our audit experience and background, please contact us for more information.