The customer needed a new, fully validated SAP instance in less than eight months to implement a new IT architecture for its pharmaceutical facilities.
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 drugs product, and primary and secondary packaging services.
The Situation
- Customer embarked on the creation of a global pharmaceutical contract manufacturing capability with eight facilities in the United States and the European Union
- 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
The Solution
- USDM created the CSV approach and instituted the process for all eight sites in the U.S. and EU
- 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 to support 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
- USDM supported hosting at an external data center and the move to a new hosting company to meet European privacy and data residency requirements
- 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.
The Results
- Nearly 40% fewer incremental testing requirements
- More than 50% reduction in original validation timeline
- Mitigated risk and effort for future upgrades