Challenge
A clinical-stage biopharmaceutical company that discovers, develops, and delivers transformative therapies for unmet medical needs needed to modernize its enterprise systems. Its clinical pipeline includes treatments for immune and fibrotic diseases as well as immuno-oncology therapies, supported by operations across multiple U.S. sites.
The company faced a tightly constrained modernization effort with several pressures converging at once:
- It needed to upgrade its Oracle E-Business Suite (EBS) release 11i to Oracle Enterprise Resource Planning (ERP) Cloud.
- The team had to implement the system, migrate data, and validate the new ERP system in six months — in the middle of a pandemic and during end-of-year holidays.
- It needed a trusted partner to manage ongoing quarterly cloud releases without falling out of a validated state.
- With a very limited budget and a small project team, the company could not handle the entire validation on its own.
Approach
USDM moved the customer from traditional computer system validation (CSV) to a risk-based computer software assurance (CSA) approach, concentrating effort where patient and product risk is highest. This kept the program aligned with 21 CFR Part 11 expectations while removing low-value scripted testing. CSA deliverables included:
- Validation plan and high-level risk assessment (HLRA)
- User requirement specification (URS), system requirement specification (SRS), and risk assessment
- User acceptance testing (UAT) for low-risk items
- Scripted and extensive testing for high-risk items
- Installation qualification (IQ) and configuration verification
- Immediate deviation handling
By tiering testing to risk and handling deviations immediately, USDM expedited the customer's validation efforts and protected data integrity throughout the data migration. The same risk-based discipline produced reusable assets so the customer could stay validated through each Oracle Cloud quarterly release rather than re-validating from scratch.
Results
USDM completed the customer's ERP validation on time, on a compressed timeline, and at a meaningfully lower cost than a traditional CSV effort would have required.
- 6 months to upgrade, migrate data, and validate the new system.
- The customer saved ~40% of the original validation estimate.
- USDM leveraged new CSA guidance by moving the customer from CSV to a risk-based assurance model.
- The customer gained assets to keep its system validated during Oracle Cloud quarterly releases.
“Thank you very much for your help, accommodating attitudes, and flexibility. This has not been an easy project for us, and you have been so flexible and willing to problem-solve with us to hit our timeline goals. Truly a great partner in this project!”
~ Senior VP & CIO
“The Validation team and QA went above and beyond to get this done. On behalf of the full implementation team, a big thank you! In my long career, the USDM validation effort is amongst the best I have ever seen!!”
~ Senior Director, Program Management
A risk-based CSA approach let this biopharma modernize to Oracle ERP Cloud in half a year and stay continuously validated through every quarterly release — faster, leaner, and audit-ready. Explore how USDM Continuous Compliance can do the same for your enterprise systems.