Certificates – Compliancy

We have successfully delivered projects to our customers within the EU and US regulatory landscape and our products and services have been reviewed and audited both directly and indirectly as a result of FDA and EU regulatory inspections. Certificates and compliancy is very important to be successful.

Certificates

Iperion is ISO27001:2013; Information Security Management certified.

 

 

 


Compliancy

Furthermore, we meet the following regulations and work according the following standards:

  • ISO9001:2015; Quality Management
  • NEN7510:2011; Information Security in Healthcare
  • FDA 21 CFR Part 11; electronic records & electronic signatures
  • Eudralex vol. 4 annex 11 Computerised Systems

U.S. FOOD AND DRUG ADMINISTRATION (FDA) LOGO EMA2