MES: Manufacturing Execution System |
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Tags: 21 CFR 11. Database. Manufacturing Execution System. Pharmaceutical. Software Validation. Test Design. Web Based Software. |
| Situation: |
| The customer is a Fortune 500 health care company and a leader in plasma-based therapies. The project involves performing white box and gray box testing of a Web-based manufacturing execution system (MES) for disposition and distribution of blood plasma. |
| Obstacles: |
| Processing the units, cartons, and batches through the system involves stepping through a sequence of multiple screens. Screens may have error conditions that are recoverable. Screens may require supervisor dual signature approval. Screens may need to segregate units that are unusable. Such as if the donor’s lab results indicate HIV or other virus. Re-loading of the Oracle database requires elevated privileges and all testing is interrupted. |
| Actions: |
| Designed a strategy for tests and data that are pre-loaded customized per screen, with multiple scenarios possible per screen. This allowed multiple testers / test cases to work independently in parallel without side effects. Developed SQL code to load the database with scenario test data, and to read the audit trail data from the database for verification. |
| Results: |
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