- 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.
“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
to upgrade, migrate data, and validate new system
of the original validation estimate
by moving from CSV