Independent QA Department plans and conducts internal audits of all departments
Organize Sponsor’s or third party’s audit / assessment
Perform vendor assessment/audit
FMD’s Quality Assurance team designs audit plans and conducts QA audits to ensure the clinical studies managed by FMD are of the highest standard and in compliance with internal company requirements, the Sponsor’s SOPs, study protocols, Good Clinical Practice, and relevant local regulations. The Quality Assurance team proactively develops and maintains FMD’s quality systems and procedures to align with changes in laws, standards and regulations and to ensure process improvements.
The QA department ensures that all quality operations supporting Phase II-IV operations are in compliance with GCP, GLP and regulatory requirements. The department’s responsibilities include but are not limited to maintenance of systems that govern the quality areas such as change control, document control, training, project/system internal audits and validation.