Rapid Compliance for Emerging Companies
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Client Profile 

  • Pre-Commercial Biotech, West Coast
  • Departments: Regulatory Affairs, Data Management, and IT
  • Team: Project Manager, Subject Matter Experts, Validation Team 

The Situation

  • Emerging BioTech company implementing capabilities for EDC and eCTD Publishing without Computer System Validation procedures in place. 
  • Needed retrospective validation and acceleration of CSV for systems. 
  • Patient enrollment was to begin in less than 60 days, and FDA submission deadline coming fast.

How We Solved It

  • USDM's Compliance team to develop, plan, remediate, and execute the validation life cycle activities: 
    • Review of documentation & gap assessment
    • Develop SOPs for CSV
    • Planning for remediation
    • Remediated all systems with minimal business owner support
    • USDM provided consulting & delivered accelerated validation for Publishing and EDC systems in a month and a half 
    • USDM developed a comprehensive CSV Program and IT CSV Procedures: CSV SOP, Change Management, Disaster Recovery, IT System Security 
    • System Admin and End User SOPs developed and approved within 3 weeks of launch
    • End-to-end compliance from USDM

6 Weeks CSV Program Setup and Validated EDC and eCTD

77% FASTER implementation of CSV Program and Application Validation

Key Takeaways

Have Questions? Get in touch, we're here to help

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