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 created standardized processes that saved the customer more than half a million dollars across five sites over two years. SME and validation team support ensured consistent, highly efficient project plans that delivered a 25% reduction in validation cost while managing peak demand and issue resolution.
The Challenge
The customer — a contract manufacturing organization (CMO) — was in heavy acquisition mode and needed to rapidly bring new plants online and assimilate them. Both the CMO and the new plant staff had minimal compliance experience, and there was no global compliance program in place to lean on.
- No global compliance program across the growing footprint of acquired plants.
- No validation, qualification, and testing resources to execute complex enterprise applications like ERP (SAP), LIMS, and Empower.
- A clear need for a partner to develop a strategy that would reduce the validation costs of future acquisitions.
- Executives wanted predictable, repeatable spend on compliance instead of one-off project surprises.
Standing up regulated enterprise systems at speed — while keeping data integrity and 21 CFR Part 11 obligations intact across every new site — is exactly the kind of scale problem that breaks ad-hoc validation approaches.
The Approach
USDM set up a global validation strategy to validate the customer's enterprise systems (SAP, LIMS, and Empower) for each new site, then operationalized it through a dedicated delivery team.
- Created standardized processes, templates, and automation programs to assess, disposition, and validate applications within each site — applying computer software assurance thinking to focus effort where risk is highest.
- Monitored ongoing KPIs and reported them to leadership, so the program stayed accountable to results.
- Began the engagement with strategy and ended with a results-based delivery program, driving standardization and efficiency across multiple plant acquisitions.
- Created a dedicated POD unit (Predictable Operational Delivery) and developed customer-specific SOPs for POD operations.
- Managed onboarding, training, performance management, and offboarding of the POD so the customer didn't carry that overhead.
- Extended SME support and extended validation team support to manage peak demands and resolve issues without slowing site go-lives.
Why a managed program
A dedicated POD delivered consistent quality and predictable delivery — the foundation of a continuous compliance model where validation is a repeatable program, not a recurring fire drill. That repeatability is what made each subsequent acquisition cheaper and faster than the last.
The Results
- 25% reduction in validation costs.
- 6 months faster onboarding time per site.
- $570K saved in SAP deployment costs for 5 sites over 2 years.
By turning compliance from an unpredictable, site-by-site scramble into a standardized managed program, USDM gave the customer the predictable spend its executives wanted — and a validation engine that scales with every new acquisition. Talk to USDM about building the same repeatable validation strategy across your sites.