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Pharmaceutical Statistical Process and 21 CFR Part 11 Compliant Emulation

The emulator includes a custom scripting language. We use the custom scripting language to run the same test repeatedly, or run a number of tests consecutively, and minimize developer effort. We can also use the script to automate and document factory acceptance tests (FATs).

The developer used this particular script to show during FAT that an improperly manufactured consumable was appropriately rejected and not released to distribution, and, that all of the statistical data related to the event appeared correctly in the statistical process control (SPC) system.

The demonstration occurred on the bench thousands of miles from the customer site.