Case Studies

A large biopharmaceutical company embarked on a digital transformation journey to gain efficiency and improve processes from drug discovery to product commercialization. They chose Veeva Vault Development Cloud as the standard for all GxP applications including Quality Suite, Clinical Suite, and Regulatory Suite.

 

Improved Quality: The customer migrated from legacy GxP applications to Veeva Vault

Significant Reduction in Operating Costs: The introduction of the Veeva Vault Suite as a standardized platform vs. disparate legacy applications

 

The customer needed a partner who could help them create a roadmap for adopting Veeva Vault as a platform for their Quality and Development Systems. They needed a trusted partner to implement Veeva Quality Suite and migrate legacy applications to the new platform. There was a need to establish an efficient process for the Veeva Vault program to accommodate periodic updates R1/R2/R3 every year. The customer wanted to expand this program to Veeva Vault Clinical and RIM Suites. As the program expanded, there was a strong need to streamline Veeva Vault application management and efficiently manage the operating costs while expanding the services to the business users.

Implementation Highlights

• Strategy and Roadmap: Spotline team strategically aligned Veeva Vault implementation roadmap with organizational goals. 
• Implementation Services: As a full-cycle Veeva Quality and eTMF implementation service provider, the Spotline team engaged with the customer for configuration and customization of Veeva Vault modules, designed and built integrations with existing line-of-business applications.
• Business Outcomes: The implementation of multiple Veeva Vaults (Quality, Clinical, and RIM) brought transformative results, marking a significant milestone in leveraging a modern GxP platform that enabled the customer to innovate rapidly and speed up the go-to-market for new treatments.
• Efficiency Leap: Veeva Vault, coupled with the Spotline MSP program, drastically reduces the operating costs for the customer in maintaining their GxP applications.
• Post-Implementation and Application Managed Services: The Spotline team engaged in ongoing maintenance and support for Quality, eTMF, and RIM Veeva Vault environments. Performed regular updates (R1, R2, & R3 releases from Veeva), impact assessment, patches, and bug fixes keeping Veeva Vaults optimized.
• Release Management Services: As Veeva typically has three releases per year for continuous platform enhancements, and the customer has 2-3 additional releases for their specific configurations and processes, it's a costly and time-consuming process to keep up with the testing and validation for multiple vaults.
• Efficiency Leap: Veeva Vault, coupled with the Spotline MSP program, drastically reduces the operating costs for the customer in maintaining their GxP applications.
• Enhanced Compliance: The Spotline team leveraged their V-Assure solution to automate Veeva Vault testing, so the customer is now able to ensure that their applications are always working as intended and are 100% GxP complaint. 
• Optimized Operation: With the Spotline hybrid team (offshore+onshore), the customer is able to support their global business users around the clock without incurring enormous operating costs.

Conclusion

Spotline's deep heritage and dual-certified partnership with Veeva empowered the biopharmaceutical leader to standardize their GxP systems on Veeva Vault. Their Managed Services Program and V-Assure solution enabled seamless implementation, automated testing, and optimized compliance, ultimately helping the customer accelerate their innovation in cancer treatment.