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
Learn more about USDM's Salesforce GxP digital transformation services.
 

$500k+ SAVED THE FIRST YEAR in license costs

Continuous Cloud Compliance

Optimized Salesforce for GxP functionality

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