Watch the ERP systems compliance and validation webinar!

Go to Webinar
(312) 207-5800
Industry: Diagnostics

Background This not-for-profit organization represents more than 6,200 surgeons, researchers and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest.

Business Issue The organization maintains a registry of patient outcomes that is incorporated into various application software solutions to assist clinical sites in addressing many areas of surgical and interventional vascular medicine. A certification program is required to ensure that the vendor applications properly utilize this registry information for maintenance, inquiry and reporting purposes.

The Objective Implement a vendor software certification program specific to this health registry.

The Solution Starting with a detailed data specification, Arbour Group constructed a comprehensive testing regimen that was implemented for each vendor solution. This package included:

  • Audit Test Plan: Described the overall approach to testing, including data element and software function testing
  • Audit Manuals: The specific test protocols to verify the following:
    • General features
    • Record management
    • Data entry
    • Field dependencies
    • Data quality and completeness checks
    • Data import
    • Record subsets and queries
    • Reporting
    • Data export for analysis by user
    • Data harvest
    • On-demand updates
  • Test Data Sets: Specific data used to prove test outcomes
  • Audit Reports: Actual results of testing, including any software non- conformances

Identified non-conformances were addressed by vendor fixes to the software and retested. Certification was granted once a vendor satisfied all the criteria tested in the Audit Manuals.