The challenge

To assist the Quality Team within Barts Health Pharmaceuticals by reviewing documentation within the quality management system (QMS) for 12 weeks. The project also required on-site presence and as a number of staff could not attend the site, additional resource was required.

Our approach

NEL addressed known issues identified in a Medical and Healthcare Regulatory Agency (MHRA) inspection and a remote MHRA inspection was being undertaken at the time. This included reviewing all open cases and conducting a full retrospective review of cases going back to the beginning of 2019, as well as a large number of cases from 2018. This involved undertaking gap analysis of process and documentation to make recommendations for improvement and was incorporated within standard operating procedures and training.

The outcome

The team were able to provide assurances to the MHRA that they are taking steps to improve QMS documentation, and ensuring that all root causes of historic cases have been addressed so as to prevent recurrence. The MHRA acknowledged this in their inspection report and commented that the quality of documentation had improved since the last inspection.