Driving Standardization and Efficiency for Multiple Plant Acquisitions

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 client over half a million 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.
  • KPIs and Metrics were monitored and reported to leadership.
  • Engagement began with strategy and ended with Output based / Results based delivery program. Driving Standardization and Efficiency for Multiple Plant Acquisitions CS011A_CW
  • Created a dedicated a POD unit (Predictable Operational Delivery unit).
  • 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.
  • Emerging Biotech company implementing Quality Management.
  • System (QMS)
  • Learning Managemnet System (LMS), Active Directory, and Okta Single Sign On.
  • Needed Project Management and accelerated Validation to enable commercialization activities.
  • FDA approval was ancitipated to be completed within 2 months.
  • These applications were the client’s first GxP applications.
  • Accelerated timelines of 12 weeks.
  • Emerging Biotech company implementing Quality Management.
  • System (QMS)
  • Learning Managemnet System (LMS), Active Directory, and Okta Single Sign On.

25% REDUCED VALIDATION PROJECT COST VARIANCE

Highly efficient project plans that resulted in 25% reduction in validation cost while managing peak demands and issue resolution.

Diane Gleinser USDM Life Sciences

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