What We Do
Closed Loop Quality Ltd. is able to provide GCP auditing services for a broad range of subject areas including, but not limited to the following:
- Investigator site audits
- System and process audits
- Vendor audits (including qualification)
- Document audits
- For-cause audits
Audit Preparation and Planning
Ensuring effective audit planning is central to our auditing methodology and in achieving a successful audit outcome. Every client audit is unique, and so to reflect this careful attention is placed during audit preparation on identifying the key scope requirements for assessment, and requesting the right documentation, to enable audit activities to be adapted accordingly to meet client needs.
Closed Loop Quality Ltd. places great emphasis on systems and process analysis during preparation for every audit, as it is recognised that these are essential elements in an organisations ability to achieve quality right-first-time.
Audit Execution
Like all great plans, audit strategies rarely survive implementation, and must be flexible enough to change as events unfold. Closed Loop Quality Ltd. works to ensure that progress during each audit is closely monitored, and is modified accordingly should new information become available to ensure a successful audit outcome is achieved.
Closed Loop Quality Ltd. are specialists in process-interrogation, as well as in interviewing personnel, with the aim of building during each audit a picture of how process compares to the actual practice observed. We understand the need to bring personnel on-board during the journey to ever greater quality, and so seek to foster a positive quality mind-set to enable organisations to realise the true potential of their quality management systems.
Audit Follow-up
Closed Loop Quality Ltd recognises that the true work for many organisations during an audit starts at the close-out meeting itself. We are experts in providing guidance on advising organisations as to the best approaches to take in addressing audit observations, and in performing root-cause analysis.
We also provide services for the review of audit responses, and are well-versed in advising organisations on the generation of robust corrective and preventive action plans.