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Pharmaceutical Company Transitions to CSA Model with USDM Expertise


Learn how USDM helped a pharmaceutical company achieve greater efficiencies in their validation process through a hybrid CSA model for testing

USDM worked in collaboration with a large pharmaceutical company to help update its internal validation processes. This enhanced the efficiencies of the company’s testing activities. With USDM’s expertise and assistance, the company moved away from a CSV model to a new hybrid CSA model.

The Situation
  • A pharmaceutical company focused on research, development, and manufacturing-focused primarily in dermatology, oncology, and specialty injectable therapeutic areas
  • The company had a cumbersome CSV process in place for validation
  • Their validation processes were time-consuming and required an excessive amount of documentation
The Solution
  • USDM worked in partnership with the company’s internal team to re-work their entire validation structure
  • USDM moved the company’s internal processes from a traditional computer system validation (CSV) to a hybrid computer system assurance (CSA) process
  • USDM helped the company to recreate internal SOPs and templates to gain efficiencies

The Results

  • The company significantly reduced the number of scripted tests in their validation processes
  • They reduced the amount of time spent documenting procedures, allowing more time for critical testing
  • USDM created comprehensive, standardized procedures for the customers’ testing activities and helped train internal teams


“USDM provided a great framework for re-aligning our cumbersome CSV process to adopt the CSA methodology.  Their experience and insight on this true risk-based approach really helped shift mindsets from documentation-focused to testing-focused. The draft procedures and tools they collaborated with us on are now the basis for CSV at our company.” – Process & Project Development Engineer

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