Slingshot Announces Tools to Expedite Pharma Software Validation in G2-16.1
Slingshot provides inventory control and manufacturing software for pharmaceutical companies. This offering includes documentation to support the FDA requirement for software validation as specified in regulation 12CFRPart11. A number of enhancements were added to this facility in release G2-16.1 including the ability to require and report an independent review of test results.
One hundred and fifty Operational Qualification (OQ) test scripts are provided with Slingshots applications. These are “Click by Click” test scripts. “Evidence” can be required for each test step (e.g., report, document or screen shot). Slingshot’s customers can add their own scripts to validate configuration changes or to qualify unique operating procedures. A Traceability Matrix ties the OQ scripts to documentation specifying the functionality being tested. The Quality application accessed through Slingshot’s web site records the test results for each test script / test run. A separate “Reviewer” user can be designated for each script. The status of the script and software releases are maintained automatically. A Validation Report shows all scripts, test results and reviewer confirmations. Slingshot also provides Installation Qualification documentation. This documentation is adjusted to comply with the customer’s operating environment. Slingshot deploys its products “on premise” and “hosted” on Microsoft’s Azure cloud.
For more information, or to receive a demonstration of the Quality application, contact This email address is being protected from spambots. You need JavaScript enabled to view it..