MEDIDATA’s SOPs constitute the framework for MEDIDATA’s compliance with all current standards, from ICH GCP to European legislation, and U.S. requirements such as 21 CFR Part 11 and FDA guidelines. SOPs are reviewed and updated periodically, both on a regular schedule and if changes become necessary.

MEDIDATA’s compliance with SOPs and current legislation and standards are reinforced by regular trainings provided centrally, by group leaders, or externally.

Our SOPs are embedded in MEDIDATA’s comprehensive Quality Assurance system. MEDIDATA’s Quality Assurance Manager sets up a QA plan for each year, giving details of the planned QA procedures. One of the important QA tools are inhouse quality audits. The QA Manager conducts these according to the annual risk-based internal audit plan and upon sponsor requests.

MEDIDATA’s SOP and Quality Assurance system is also regularly examined by sponsors and external organisations. MEDIDATA’s QA system passes several sponsor audits annually. As a matter of course, both external and internal audits play an important role in continuously improving our SOP and QA system.