Documentation Index

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Results review

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Life Sciences Quality Control & Assurance allows users to perform a formal review of test results, as required by GMP guidelines; this means that paper-based approvals are significantly reduced.

When an authorized employee, for example the QC supervisor, formally reviews a test result (i.e., tick the Reviewed checkbox for the quality order line), the system keeps track of the review activity and stores the reviewer’s user ID in the Reviewer field. Reviewed results are not editable for any user but the one that has reviewed them.

In case of tests linked to an attribute (e.g., Potency), it is possible to enable the Update inventory batch attribute after review parameter to automatically assign the test result as a batch attribute when the quality order line is reviewed.  The parameter is also available in the test groups. Reviewed results are not editable for any user but the one who has reviewed them; if the reviewer modifies the result, the Reviewed checkbox is automatically unticked.

In case of tests linked to an attribute (e.g., Potency), it is possible to enable the Update inventory batch attribute after review and Update inventory sub batch attribute after review parameters to automatically set test result as a batch attribute/sub-batch attribute once the quality order line is marked Reviewed. These parameters are also available in test groups.