Establishing a risk-based, phase-appropriate path to a compliant-ready position
Start-up companies must decide how they will manage compliance for their GxP computer systems by establishing an IT compliance program for validation and change management — a computer system validation (CSV) program. USDM can fast-track this effort, even under tight regulatory deadlines.
The Challenge
A pre-commercial biotech company was implementing new capabilities for EDC and eCTD publishing, but had no CSV procedures in place. With systems already going live, the company needed both retrospective validation of existing work and acceleration of its overall CSV effort.
The timing left no room to spare:
- Patient enrollment was set to begin in less than 60 days.
- An FDA submission deadline was quickly approaching.
- No foundational CSV program, SOPs, or change management process existed to support the systems being deployed.
Without a validated environment, the company risked data integrity gaps and a non-compliant position on the very systems its clinical and regulatory milestones depended on.
The USDM Approach
USDM planned, developed, and executed the full validation life cycle with a pragmatic, risk-based methodology aligned to computer software assurance principles. The work included:
- Review of documentation and a gap assessment
- Development of SOPs for CSV
- Planning for remediation
- Remediating all systems with minimal business owner support
A complete CSV program, not just procedures
Rather than stopping at validation paperwork, USDM developed a comprehensive CSV program and the procedures to sustain it — including the CSV SOP, change management, disaster recovery, and IT system security. This gave the client a foundation for ongoing compliance and life sciences cybersecurity well beyond the initial deadline.
USDM developed and secured approval of both system admin and end-user SOPs within 3 weeks of launch, and delivered end-to-end compliance across the EDC and eCTD publishing systems — supporting the client's 21 CFR Part 11 obligations for electronic records and signatures.
The Results
USDM established a compliant-ready position fast enough to keep the client's clinical and regulatory milestones on track:
- 6 weeks to CSV program setup and validated EDC and eCTD publishing systems
- 77% faster implementation of the CSV program and application validation
- System admin and end-user SOPs approved within 3 weeks of launch
- End-to-end compliance delivered with minimal business owner support
By building a risk-based, phase-appropriate program rather than a one-off validation effort, USDM left the biotech with a sustainable CSV foundation — ready for patient enrollment, the FDA submission, and the systems it would add next. Explore how USDM keeps validated systems compliant over time through continuous compliance.