Every sample type a plant tests
Sample types cover raw material, in-process, finished product, stability, water, environmental, API, intermediate, bulk, microbiology, sterility, endotoxin, cleaning validation and recovery. Every type follows the same register, assign, enter and review flow, with the same controls.
Verdicts that cannot be rewritten
When a test is assigned, the limits from the effective specification version are frozen onto it. Each result is classified within limits or OOS against those frozen limits. A correction never overwrites: a new observation replaces the old one on screen, the original is kept in the record, and the correction needs a reason and an e-signature as described in 21 CFR 11.50.
From the lab to release
Reviewed results feed the batch release evidence package, so the person releasing a batch sees the QC record behind it. An out-of-specification result is investigated in the OOS & Lab Incident Investigation module, and a reconcile job keeps sample status consistent with its tests.