Case Study:

Laboratory Client Competing for a Large Contract Prepares for Audit


Our Client:

A laboratory client requested that Safis Solutions audit their processes, documentation, and overall quality system in preparation for an audit by a pharmaceutical company. The audit was a critical step for the laboratory to win a contract to provide clinical trial sample analysis services.


Safis evaluated the Client’s quality systems relative to GXP regulations, performed a gap analysis and assisted in the development of an action plan that was presented to the pharmaceutical client during the audit.


After the audit, Safis drafted a response letter to the pharmaceutical firm noting the action steps that would be taken to address the audit findings. Subsequently, Safis was engaged by the client laboratory to provide quality consulting services. Safis assisted with procedure centralization, development, and document control. Safis provided Quality Assurance oversight to align procedure consistency within the company.


Our client was awarded the contract and provided clinical trial analysis services critical to a drug submission to the FDA.