USDM delivered restructured data systems while ensuring continuous compliance and reduced risk
Learn how USDM saved a biopharma company with $30B in annual revenue more than $500k in licensing fees by implementing Salesforce GxP capabilities, which created baseline and automated testing as well as risk-based validation.
The Situation
- Leading biopharma company with more than $30B in annual revenue
- Dozens of platforms used by more than 8,000 employees
- Entrenched belief that Salesforce could not be used in a qualified way
- Minimal cloud adoption for GxP use cases
- No compliance framework for assessing and maintaining a validated state for cloud based applications
The Solution
- USDM established a robust cloud compliance framework to manage risks
- USDM implemented Cloud AssuranceTM for Salesforce to create baseline and automated testing to maintain a continuously compliant state
- USDM then established risk-based validation commensurate with intended use of system, regulatory rigor, technical complexity, business risk, and data integrity risk
- USDM’s VAP provided baseline qualification/validation deliverables
- An annual Salesforce audit was included as part of the subscription
- Validation augmented by SQA (automated) testing and Functional Risk Assessments Validation vs. Qualification Qualified underlying common capabilities (features and functionality)
- Established simplified end-use validation based on verifying configurations of common capabilities; user acceptance/PQs; and extensive validation only for unique capabilities
The Results
- $500k+SAVED THE FIRST YEAR in license costs
- Continuous Cloud Compliance
- Optimized Salesforce for GxP functionality
Learn more about USDM’s Salesforce GxP digital transformation services.
