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