Transitioning from CSV to CSA case study
Kadmon is a clinical-stage biopharmaceutical company that discovers, develops, and delivers transformative therapies for unmet medical needs. Their clinical pipeline includes treatments for immune and fibrotic diseases as well as immuno-oncology therapies. The company is based in New York City and has operations in Warrendale, Pa., and Cambridge, Mass.
- Kadmon needed to upgrade their Oracle E-Business Suite (EBS) release 11i to Oracle Enterprise Release Planning (ERP) Cloud.
- They needed 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.
- They needed a trusted partner to manage quarterly cloud releases.
- They had a very limited budget and a small project team, and could not handle the entire validation on their own.
- USDM moved Kadmon from a traditional computer system validation (CSV) to a computer software assurance (CSA) approach. 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
- USDM expedited the customer’s validation efforts.
- USDM completed the customer’s ERP validation on time.
- USDM helped the customer develop assets to keep their system validated during Oracle Cloud quarterly releases.
- USDM’s partnership saved the customer ~40% of the initial estimation for the validation effort.
- 6 MONTHS to upgrade, migrate data, and validate new system
- Customer saved ~40% of the original validation estimate
- Leveraged new CSA guidance by moving from CSV
“Thank you very much for your help, accommodating attitudes, and flexibility. This has not been an easy project for Kadmon, 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!”
~ Peter Buniak, 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!!”
~ James Finley, Senior Director, Program Management
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