Is your organization required by law to operate a pharmacovigilance system and have it routinely audited? If so, DQS is the perfect partner to perform your system audits. 

DQS is a partner of the German Medicines Manufacturers’ Association (BAH), the industry body that has defined the audit requirements for these systems. However, DQS also considers applicable regulations and your organization’s situation in its audit.

  • BAH Requirements
  • Medicine Manufacturers
  • Compliance
  • Risk Management

The audit requirements for pharmacovigilance systems were developed by the German Medicines Manufacturers’ Association (BAH) with experts from BAH member companies. They consider relevant regulations as well as the situation at small and medium-sized enterprises. System audits primarily aim to review the effectiveness of your pharmacovigilance system and detect weaknesses and opportunities for optimization. Being a BAH partner and an impartial third party, we can conduct system audits at your organization and help you meet your legal obligation to have your pharmacovigilance system periodically audited.

  • Documented compliance of your pharmacovigilance system with BAH pharmacovigilance requirements 
  • Widely accepted evidence of compliance with your legal obligations
  • Lower costs thanks to the partnership between BAH and DQS
  • Potential avoidance of multiple audits by partners 

First, we thoroughly check and appraise your pharmacovigilance system master file (PSMF) to determine whether a system audit can be performed. The audit is performed onsite under the supervision of two auditors based on random samples. If you meet all the BAH criteria, you receive a three-year certificate documenting your compliance. In the next two years, you prepare status reports documenting things such as changes to your pharmacovigilance system. We review these reports as well. After three years, we conduct another complete system audit. 

Ihr Kontakt rund um ISO 9001
Quotation request

Your contact person Regine Bullon-Haro:

"We would be happy to provide you with a customised offer for the pharmacovigilance audit."


Cost Estimate

Energy Savings and Lower Costs Go Hand in Hand

As long as you have an energy management system certified to ISO 50001, that statement is true for you. This standard promises to improve energy efficiency and drive sustainability in your business. And if you satisfy the legal requirements, you might do more than just benefit the environment. You might lower your tax bill, too. 

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