We provide support and consultancy in software/hardware system validation. This includes company requirements in virtual environments and computer centres abroad.
- Software and hardware analysis and classification into the GAMP categories*
- Validation risk-based approach
- Validation document creation support
- Risk analysis
- Carrying our periodical reviews
- Validation implementation and collaboration.
- Test case implementation and collaboration (IQ,OQ)
*GAMP is categorized as follows:
- Category 1: Infrastructure Software
- Category 2: disused
- Category 3: Non-Configured Products
- Category 4: Configured Products
- Category 5: Custom Applications