A-pharmaconsult internal and external QMS audits

In its role as a trusted Quality Assurance (QA) partner to life sciences companies, A-pharmaconsult offers a full audit service for companies needing to evaluate or optimize their Quality Management Systems (QMS).

The A-pharmaconsult QMS Auditing Service includes a range of internal or external audits that provide an accurate measurement of the implementation of the client organization’s QMS regarding both the efficiency of its procedures and its compliance with applicable legal requirements.

Full scope

Regulatory regimes covered by the service include GMP, GDP, ISO13485:2016, ISO22716, as well as the ‘Exploitant’ status applied in France to companies performing commercial activities related with medical products that include distribution of medicinal products, communications, pharmacovigilance, and batch control.

Activities covered by the audit service include Good Manufacturing Practices, ISO 13485, Medical Device Regulation (MDR 2017/745), Good Distribution Practices, ISO 22716 for Active substances, Finished products, Medical Devices, and Cosmetics.

These QA and QC audit services draw on the accumulated knowledge and expertise of the A-pharmaconsult team, it includes professionals who are highly versed in all relevant clinical, medical and scientific regulatory affairs fields.