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.
- 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