Confirmed by audits of DNV-GL and BVMA
Two independent audits were conducted at proDERM in September. On the one hand, the audits focused on the recertification of our management system according to ISO 9001:2015 by DNV-GL, a globally operating certification company. On the other hand, we were re-audited by the German Federal Association of Medical Contract Research Institutes (BVMA) with regard to compliance with the quality standards required by the association.
The main topic of the DNV-GL audit was the process of ‘report generation, dispatch and invoicing’. We were attested a high level of process control. The management system as a whole was considered effective and compliant with the standards. Therefore, the certificate issued to us, which confirms compliance with the requirements of ISO 9001:2015, remains valid.
The BVMA re-audit focused on the implementation of ICH GCP (R2) in general. A special focus was placed on risk management, quality management and data management.
Overall, the auditor’s report attests us a good organization and management. Although potentials for further optimization were identified in a few areas, we are pleased to report that, despite all the entrepreneurial dynamism, compliance with the GCP requirements for the conduct of clinical trials was independently confirmed.