Software Validation | Regulation

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Regulation Glossary

Regulation

We know the international standards and regulations

We are acquainted with national and international standards.

Pharmaceutical and medical device

GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
FDA GMP, GLP, QSR and Electronic Records
European GMP and Annex 11
Swissmedic
PIC/S

Software development, maintenance and services

Certified training for software professionals