QA Audits

Based in the Netherlands we offer independent quality assurance services in Europe with no geographic limitations. We have conducted over 160 audits throughout Western and Eastern Europe, Asia and the United States of America. We have conducted audits in the Netherlands, France, Ireland, Belgium, Hungary, Poland, Germany, United Kingdom, Switzerland, Italy, Latvia, Czechia, Slovakia, Croatia, Serbia, Russia, Spain, China and India. Our multilingual capacity (English, German, French and Dutch) enables us to conduct the documentary review and discussions at sponsor and investigator sites. The final audit report and the audit certificate are produced in English. We focus on the following audits:

  • Routine investigator site audits for clinical trials to confirm ICH GCP and ISO 14155 compliance, data authenticity at source or data integrity during processing
  • Organization audits of Clinical R & D systems for the pharmaceutical and medical device industry or research institutes
  • Qualification audits for clinical research suppliers (CRO, Central Laboratories or Core Laboratories)
  • Audits of Pharmaco- and Device vigilance activities
  • Audits of Pharmacy departments engaged in clinical drug research

We have established the following methodology:

  • Discussion with the client on the scope of the audit
  • Development of an audit plan including detailed task/responsibility list and time plan
  • The audit plan will be incorporated in an offer
  • Organization of the audit and visit relevant locations
  • Documentation of all objective audit findings and recommendation in an audit report
  • Presentation of the findings and recommendation to your staff