The Situation
The organisation wanted to perform GLP studies in non-commercial veterinary operating theatres with unvalidated equipment, and a lack of awareness of current regulatory guidance
The Solution
DQA put forward a team of experts who were able to diagnose the issues, produce a remediation plan and implement the solution, as a right first-time exercise so that the client could successfully take regulated work from a client.
Results
The organisation successfully ran the GLP studies in an environment that was compliant with GLP regulations and was advised on future advances for further compliance efforts, to ensure that they continued to work to GLP.
DQA Advantage
Adaption. DQA Experts were able to adapt to the non-commercial environment and ensured that they had the correct controls in place, for a right sized approach to validation, which encompassed GLP compliance, and remained on-call after the completion of the project to ensure that any questions or queries could be answered and challenges mitigated.