Last November, I wrote about the new release of Oracle Clinical, Remote Data Capture (RDC), and Thesaurus Management System (TMS), version 5.1. As many companies continue to run these “tried-and-true” clinical data management and EDC systems, the enhancements were quite welcome.
Since then, our data management team has been developing a complete Validation Suite for the new release to help companies speed up their 5.1 implementations/upgrades without sacrificing peace of mind or compliance.
Our new OC/RDC/TMS 5.1 Val Suite includes:
- Functional Requirements Specification (FRS) that describes the out-of-the-box functionality provided by Oracle
- Ready-to-execute Operational Qualification (OQ) Test Suite that tests all of the requirements in the FRS
- Traceability Matrix that maps the OQ test cases back to the requirements they test
- Microsoft Word templates for validation deliverables, such as a validation plan, qualification protocol, qualification summary report, and validation summary report
Each organization has its own preference for handling computer system validation (CSV). Some manage it entirely in-house. Others completely outsource it. But most prefer to purchase pre-packaged Val Suites, which is why we go through the trouble of creating them!
We also offer test execution services, implementation and upgrade services, and comprehensive validation services, depending on what you need.
For more information about OC/RDC/TMS 5.1, the 5.1 Val Suite, or any of our other data management services, feel free to reach out.