A cloud GxP platform that goes wherever the business needs it

Learn how USDM saved a $30B annual revenue, Biopharma company over $500k in license costs by implementing a Salesforce Platform VAP, which created baseline and automated testing as well as risk-based validation.

USDM delivered restructured data systems across the enterprise, while ensuring continuous compliance and reduced risk.

The Situation

  • Leading Biopharma company with over $30B in annual revenue
  • Dozens of platforms used by over 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, validating and maintaining a validated state for cloud based applications

The Solution

  • USDM established a robust cloud compliance framework to manage risks
  • USDM implemented Cloud Assurance 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 simplfied end-use validation based on verifying configurations of common capabilities; user acceptance / PQs; and extensive validation only for unique capabilities

$500k+ SAVED THE FIRST YEAR in license costs

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