GxP System Validation and Monitoring for Half the Cost

Learn how an emerging therapeutics company saves more than $400k annually and maintains SaaS systems for half that cost.

Life sciences companies that perform their own Software-as-a-Service (SaaS) validation and ongoing maintenance may not get the return on investment (ROI) they anticipated. Particularly when more SaaS applications are added to the tech stack and the complexity and velocity of releases intensify.

Background

An emerging therapeutics company, newly commercialized, recognized early the critical importance of GxP-compliant SaaS systems to ensure product quality and meet stringent regulatory requirements. Managing eight GxP systems, however, quickly became a challenge. Quarterly, system and business owners faced the arduous task of processing 35 to 40 change controls, increasing risks of inefficiencies and non-compliance.

Challenges

• Complex System Management: High volume of change controls and system updates.
• Resource Drain: Labor-intensive validation and compliance maintenance required extensive staffing.
• Compliance Risk: Potential exposure to non-compliance amidst growing complexity and rapid SaaS release cycles.

USDM’s Approach

The therapeutics company partnered with USDM Life Sciences to leverage its comprehensive suite of capabilities:

1. Trust & Compliance:
   • USDM Cloud Assurance: Delivered automated compliance validation, drastically reducing manual workloads by more than 80%.
   • DocuSign + Veeva Integration: Quarterly DocuSign reports with 99.9% accuracy and comprehensive Veeva configuration reviews simplified compliance efforts.
2. Data Insights & Control:
   • Real-time GxP system monitoring through the Cloud Assurance Digital Experience (Dx) Portal, enabling proactive management of system statuses.
3. Content Management:
   • Validated Box for GxP and non-GxP document storage, wrote SOPs, and provided end-user training, ensuring seamless and compliant document workflows.
4. Workflow Automation:
   • Streamlined validation workflows, enabling two employees to handle work that previously required a full team.

Results and Business Outcomes

1. Cost Savings: Reduced headcount by four positions, saving over $400,000 annually.
2. Operational Efficiency: Freed up highly skilled employees to focus on the company’s core mission of developing therapeutics, rather than being consumed by validation tasks.
3. Scalability: Simplified SaaS system management allows the company to confidently scale its technology stack without risking compliance.
4. Proven Accuracy: Delivered reports and validation with near-perfect reliability, reducing compliance risks and enhancing audit readiness.

By harnessing USDM’s cutting-edge capabilities, the therapeutics company now operates with greater agility, reduced risk, and a laser focus on its mission of improving patient outcomes. USDM’s innovative approach to GxP compliance and SaaS system optimization delivers measurable results, ensuring technology supports—not hinders—innovation.