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