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USDM Managed Compliance Program

Computer System Validation

USDM Managed Compliance – 25% Reduction in Validation Cost

Learn how USDM’s Managed Compliance Program drove standardization and efficiency for a global contract biopharmaceutical manufacturer in heavy acquisition mode.

By devising a global validation strategy to validate enterprise systems for new sites, USDM was able to create standardized processes that saved our customer more than half a million dollars for five sites over two years. SME and validation team support ensured consistent, highly efficient project plans that resulted in 25% reduction in validation cost while managing peak demands and issue resolution.

The Situation
  • CMO was in heavy acquisition mode and seeking to rapidly bring online and assimilate new plants. CMO and plant staff have minimal compliance experience.
  • There was no global compliance program.
  • No validation, qualification and testing resources to execute complex enterprise applications like ERP (SAP), LIMS, and Empower.
  • Seeking partner to develop a strategy that would reduce validation costs of future acquisitions.
  • Executives wanted a predictable spend on compliance.
The Solution
  • Set up global validation strategy to validate enterprise systems (SAP, LIMS and Empower) for new sites.
  • Created standardized processes, templates, and automation programs to assess, disposition and validate applications within each site.
  • Ongoing KPIs were monitored and reported to leadership.
  • Engagement began with strategy and ended with results-based delivery program. Driving standardization and efficiency for multiple plant acquisitions.
  • Created a dedicated a POD unit (Predictable Operational Delivery).
  • Developed customer-specific SOPs for POD operations.
  • Managed onboarding / training / performance management / offboarding of POD.
  • Dedicated POD provided consistent delivery / quality.
  • Extended SME support and extended validation team support allowed for managing peak demands and issue resolution.

The Results

  • 25% reduction in validation costs​
  • 6 months faster on-boarding time per site​
  • $570K saved in SAP deployment costs for 5 sites over 2 years

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