Validation

Navigating Regulatory Requirements with an Extreme Focus on Quality

Validation is a crucial portion of regulatory compliance. CXV Global utilises a GAMP 5 risk-based approach to Computer System Validation (CSV). Our Quality System has been successfully audited by many major Pharmaceutical and Biotechnology organisations with no major findings. We can either utilise our own Quality System as part of a project, or adopt and operate within your Quality System for execution and delivery. Our Quality System has been adopted and is currently in use by numerous major Pharmaceutical and Biotechnology companies because of our approach to validation.

In addition to our standard validation services we offer 21 CFR Part 11 Compliance evaluations and test plan creation and execution.

Detailed Validation Project Services

 

Validation Documents Generated and Executed

  • Project Implementation Plans
  • Project Validation and Quality Plans
  • User Requirement Specifications (URS)
  • Functional Requirement Specifications (FRSs)
  • Software Design Descriptions(SDSs) or Detail Design Descriptions (DDSs)
  • Factory Acceptance Tests (FATs)
  • Part 11 compliance tests
  • Site Acceptance Tests (SATs)
  • Installation Qualifications (IQs)
  • Operational Qualifications (OQs)
  • Requirements Trace Matrices (RTMs)
  • 21 CFR Part 11 Gap Analysis and Validation Protocols
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SOPs Generated

  • Incident and Discrepancy Reporting SOPs
  • Change Management and Control SOPs
  • System Security procedures and SOPs
  • Software modification SOPs
  • Disaster Recovery SOPs

Accessing The Technology

To evaluate how validation could best be deployed in your facilities, please contact us to arrange a line walk or remote assessment during which our engineering consultants will determine what is required for your needs and environment.