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

• IEEE software standards
• ISO software standards

Certified training for software professionals

• International Software Tester Qualifications Board
• International Requirement Engineering Board