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

6 Weeks CSV Program Setup and Validated EDC and eCTD

77% FASTER implementation of CSV Program and Application Validation