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CSV Program and Application Validation in Less than 6 Weeks


Learn how USDM helped establish a risk-based, phase-appropriate, pragmatic approach for compliance to achieve a compliant-ready position.

Start-up companies must determine how their company will manage compliance with regulations for their GxP computer systems by establishing their IT compliance program for validation and change management for a computer system validation (CSV) program. USDM can fast-track this effort for you.

The Situation
  • Pre-Commercial biotech company
  • Implementing capabilities for EDC and eCTD Publishing
  • No CSV procedures in place
  • Needed retrospective validation and acceleration of CSV
  • Patient enrollment was to begin in less than 60 days, and FDA submission deadline was quickly approaching
The Solution
  • USDM planned, developed, and executed the validation life cycle activities including:
    • Review of documentation and gap assessment
    • Development of SOPs for CSV
    • Planning for remediation
    • Remediated all systems with minimal business owner support
  • USDM developed a comprehensive CSV program and CSV procedures; CSV SOP, change management, disaster recovery, IT system security
  • USDM developed and secured approval of system admin and end-user SOPs within 3 weeks of launch
  • USDM delivered end-to-end compliance

The Results

  • 6 Weeks to CSV Program Setup and Validated EDC and eCTD​
  • 77% FASTER implementation of CSV Program and Application Validation


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