Challenge: A Fully Validated SAP Instance in Under Eight Months Across Eight Global Sites
The customer, a global contract manufacturing organization, supports various markets and supply chain segments with sterile fill-finish of sterile injectable products, oral solid dose drug products, and primary and secondary packaging services. To implement a new IT architecture for its pharmaceutical facilities, the customer needed a new, fully validated SAP instance in less than eight months.
The company embarked on the creation of a global pharmaceutical contract manufacturing capability with eight facilities in the United States and the European Union. The scale and speed of the program introduced several compounding challenges:
- Each new facility was established as an independent company for legal and contractual considerations and needed its own IT environment.
- Rapid onboarding of new sites required implementation and validation within six months.
- The new IT architecture had to include SAP, QMS, LIMS, and related lab systems.
- The customer required new SDLC and CSV methodologies.
- IT teams had inconsistent regulatory knowledge and varying experience with CSV, raising data integrity and compliance risk.
Approach: A Repeatable, 21 CFR Part 11 Compliant Validation Engine
USDM created the CSV approach and instituted the process for all eight sites in the U.S. and EU, establishing a standardized foundation that every subsequent site could reuse.
- USDM completed the initial site validation in less than six months, including the qualification of and procedures for the HP Application Lifecycle Management (ALM)—a 21 CFR Part 11 compliant testing repository—to manage requirements and test scripts in support of validation.
- Expanded validation responsibilities were accomplished for laboratory systems.
- USDM created an optimized, repeatable ALM-based approach to expedite and streamline the SAP implementation and validation for each site instance of the architecture, applying risk-based computer software assurance principles to focus effort where it mattered most.
- USDM supported hosting at an external data center and the move to a new hosting company to meet European privacy and data residency requirements—a key dimension of third-party risk management.
A Global Footprint, One Consistent Method
Including the foundational work at the initial site, USDM successfully supported the company’s global expansion to:
- Two U.S. sites
- One Puerto Rican site
- One Canadian site
- Four European sites (France, Italy, Ireland, UK)
USDM successfully supported SAP validation at eight sites in the aggressive timeline necessary for the global expansion. The validation schedule and effort were reduced by 50% for the subsequent sites by leveraging significant pre-planning, training, and the USDM-developed SAP accelerators.
Results: More Than 50% Faster, With Less Risk for Every Future Upgrade
- Nearly 40% fewer incremental testing requirements.
- More than 50% reduction in the original validation timeline.
- Mitigated risk and effort for future upgrades.
By codifying validation into a repeatable, accelerator-driven engine, USDM turned an aggressive eight-site, multi-country rollout into a predictable, compliant program—cutting timeline and effort by more than half while building a foundation that keeps every future SAP upgrade faster and lower risk. To accelerate your own validated enterprise deployments, explore USDM’s continuous compliance approach or contact us.