• Computerized System – / Software Validation
  • IT Infrastructure Qualification
  • CSV Process / QMS
  • IT Lifecycle Management
  • IT Quality Management
  • GxP Compliance
  • CSV Training

Computerized System Validation
GxP Classification, User Requirement Specification, GAMP Classification, Risk Assessment, Technical-/Functional Specification, IQ, OQ, PQ, SOP’s, WI’s, Test Scrips, Testing, Final Report,…

IT Infrastructure Qualification
Network, network components, server, storage, clients, mobile devices, printers, periphery, …

IT Lifecycle
Change Management, Incident Management, Qualification,…

IT Quality
Change Management, Incident Management, Problem Management, Release Management, Good Documetation, …