Pharma Quality Consulting

AGILE Validation in GxP Project Service

Helping Pharma clients to ensure regulatory compliance and quality in all aspects of the GxP system implementation.

Together with your business teams our consultants work to ensure the compliance of business critical computer systems.

We translate the business team language into technology provider language to ensure complete requirements coverage first and every time.

Our clients can rest assured in compliance with:

  • ICH
  • ISO 9001
  • GxP
  • GAMP 4 and GAMP 5
  • 21 CFR part 11/ EU annex 11

We Help our clients with

  • Risk Assessment
  • Software Vendor Audits
  • System Evaluations
  • User Requirements Specifications
  • UAT Testing
  • Validation Plans and Reports
  • Installation, Operational and Performance Qualification
  • Quality in Data Migration
  • Commissioning and Decommissioning Systems