Quality oversight is of the ultimate responsibility of RPM’s top-tier management. As a stand-alone function, QA and QC specialists work as a guiding light to assure the adherence to country-specific regulations, study protocols, SOPs, GxP requirements, etc. Experienced QA auditors perform risk-based quality monitoring to maintain the quality standards of RPM’s operation.

• Proactive quality monitoring includes site audits, internal system audits, vendor audits, and clinical study report audits for drug and medical device studies.
• QA auditors are also the advocator of appropriate correction & prevention of compliance issues in the right way, keeping an analytical eye on company- and study-level PDCA cycles to minimize unexpected non-conformities and deviations.

Our main business is as follows. In addition, we will respond flexibly depending on the business content.
If you have any questions, please feel free to contact us.

• Pharmaceuticals, doctor-led clinical trials, medical device audits
• Audit of clinical trial medical institutions
• System audit
• Creating audit SOPs and checklists
• Internal and external audits of individual contracted operations