In addition to standard specifications, Life Sciences Quality Control & Assurance offers internal specifications for tests. The possibility of managing internal specifications increases traceability when results must be compared against an additional set of stricter specifications (for example, based on a different regulation or on specific customer requirements).
When test results are inserted in a quality order, the system verifies the results against internal specifications. Meeting the internal specifications provides additional information about the outcome of the test, but it does not affect the final assessment. This additional verification can be enabled and disabled through the Enable internal specification button.
The internal specifications functionality is integrated with Microsoft Quick result entry form, allowing users to display internal specifications in the updated interface.
Example
External specification:
Standard: “10”
Min: “5”
Max: “15”
Internal specification:
Standard: “10”
Min: “6”
Max: “14”
If the result entered is “14.5”, the test is considered passed, but it is possible to verify that the internal specifications were not met. The outcome of the verification against the internal specifications is displayed in the Test result (Int) field (Quality order line results form).
If internal specifications are not required, it is possible to disable the Enable internal specifications parameter (available in the Test groups line and Quality order lines). In this case the system will not check the result against the internal specifications.