Starting point

• A CSV project is approaching completion

• An internal audit or an inspection of GxP-related IT applications has been arranged

• An application has been validated and approved with restrictions

• A previous validation is to be used as the basis for the revalidation of a system

• The first phase of the global rollout of a validated application has been implemented and the second phase is about to start

Our contribution

• We check your project documentation and create a GAP analysis to identify any missing elements

• We help you to fill gaps in CSV projects

• We enable you to make practical use of previous validations during revalidations

• We help you to define necessary measures to eliminate inspection risks

• We assist you in responding to audit findings with action plans

Your benefit

• Completion of incorrect validation documentation

• Creation of documentation for an application which will pass an inspection

• Qualification of IT infrastructures which will pass an inspection

• Pragmatic revalidation projects and retrospective validations

• Completion of on-going CSV projects on schedule

• Resolution of open points (findings/change requests) from completed validations