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Quality and Compliance

Our comprehensive range of Quality & Compliance services covers:

  • Risk Assessment
  • 21 CFR Part 11 System Assessment
  • GAP Analysis
  • GxP, GMP & GLP Compliance Auditing
  • Validation Protocol and Plan
  • IQ, OQ, PQ Protocols and Reports
  • Vendor Audit Questionnaire
  • User Requirements
  • Traceability Matrix
  • SOPs and Work Guidelines
  • Test Script Authoring and Execution
  • Final Validation Report
  • HIPAA
  • SOX

 

Contact us today to discuss your Quality & Compliance needs.