Panacea Technologies and CXV Global are now Catalyx.
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About Us

Validation Services

Validation is a crucial portion of regulatory compliance. Panacea utilizes a GAMP 5 risk-based approach to Computer System Validation (CSV). Our Quality System has been successfully audited by many major Pharmaceutical and Biotechnology organizations with no major findings. We can either utilize 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

SOPs Generated

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

Relevant Documents