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.
Iperion is ISO certified:
- ISO9001:2015; Quality Management
- ISO27001:2018; Information Security Management
- NEN7510:2018; Information Security In Healthcare
Furthermore, we meet the following regulations:
- FDA 21 CFR Part 11; electronic records & electronic signatures
- Eudralex vol. 4 annex 11 Computerised Systems