Consulting Services

Focusing to connect QA and IT together.

Contact for:

  • Validation services and consulting
  • Security services and consulting
  • Enterprise Information Management (#ECM / #EIM) consulting
  • GAMP5 risk analyses, process development, data flow analyses
  • Network security analyses and compliance audits (CFR 21 Part 11, EMA Chapter 4 Annex 11, ICH guidelines, PIC/S compliance)
  • Computer System Validation (#CSV), Cloud Validation, URS, FS, IQ, PQ, VMP, CSV, SOP’s and other related documentation
  • IT audits, IT quality and compliance, vendor audits and best practices
  • Contingency, Business Continuity, Disaster Recovery and Operational Resiliency planning and consulting
  • ECM vendor selection, requirements definition, security requirements definition
  • Other auditing services (ISO 27701, ISO 27001, ISO 9001 and VAHTI / KATAKRI/ SÄHKE2)