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

A newly commercialized therapeutics company recognized early on the importance of GxP-compliant systems to safeguard product quality and fulfill regulatory requirements and standards.

However, maintaining eight GxP systems posed significant challenges. Every quarter, the system owner and business owner faced the daunting task of managing 35 to 40 change controls. It was time-consuming and fraught with the risk of non-compliance.

Solution

The company chose USDM Life Sciences—which has supported more than 300 companies with similar technology footprints—to validate seven of their eight GxP systems. This strategic partnership was grounded in USDM’s deep understanding of the life sciences ecosystem and its innovative approach to leverage cloud technology to simplify compliance efforts.

USDM Cloud Assurance enabled two employees to do the work that would otherwise require an entire team.

• Three times a year, USDM provides a spreadsheet of Veeva configurations that requires only an hour of the system owner’s time to review.
• Quarterly reports submitted to the company for DocuSign change controls are deemed accurate 99.9% of the time.
• USDM validated Box for GxP and non-GxP document storage, wrote administrator and user Standard Operating Procedures (SOPs), and provided end-user training.

The company’s head of quality assurance logs in to the Cloud Assurance Digital Experience (Dx) web portal for real-time status updates of all seven GxP systems.

Results and Benefits

The collaboration between the customer and USDM led to substantial cost savings and operational efficiency. USDM reduced their headcount by four (a senior validation lead, a junior validation support person, an IT manager, and a mid-level business analyst), which equates to about $420,000 in annual expenses.

The partnership also enables the customer to achieve previously unattainable efficiency. The burden of continuously monitoring and managing frequent releases of SaaS applications is lifted and allows their highly skilled resources to focus on the core mission of developing therapeutics.

0

0