Audit & Remediation

Our Client: A laboratory was working with a pharmaceutical company to provide clinical trial sample analysis services. The pharmaceutical company was scheduled to perform an audit of the laboratory company. The laboratory client requested that Safis Solutions audit their processes, documentation, and overall quality system. Safis evaluated the Clientís quality systems relative to GxP regulations.

Upon evaluating the Clientís quality systems, Safisí team performed a gap analysis and assisted in the development of an action plan to address such gaps. This action plan 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. The Client was awarded the contract to perform clinical testing for the pharmaceutical firm.

Subsequently, Safis was engaged by the Client laboratory to provide quality consulting services. Safis assisted with procedure centralization, development, and document control. Quality Assurance oversight was provided by Safis to align procedure consistency within the company.

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