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 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.
- 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.