Validation

We provide support and consultancy in software/hardware system validation. This includes company requirements in virtual environments and computer centres abroad.

Validation constituents:

• 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