Every reagent or control lot change is a risk to result continuity. QCnomics verifies a new lot against the current one, judges acceptability against allowable total error, and stores the evidence your assessor expects.
Try QCnomicsWhen a reagent or QC lot changes, target values and bias can shift. Releasing patient results across an unverified lot change can introduce a systematic error that Levey-Jennings review may not immediately catch. NABL 112 / 112A and ISO 15189:2022 expect labs to verify comparability before adopting a new lot.
The correct primary criterion is bias against allowable total error (TEa), not correlation alone. QCnomics compares paired results from the old and new lot, computes mean bias and checks it against the analyte's TEa. Correlation (r) is used only as a range-adequacy gate — it confirms the comparison spanned a wide enough range, it does not prove agreement.
Is correlation (r) enough to accept a new lot?
No. A high r only means the comparison covered a wide range; it does not prove the lots agree. Acceptability must be judged on bias versus allowable total error (TEa), which QCnomics does automatically.
Does QCnomics track when a lot was opened?
Yes. It records in-use-from dates, open-vial stability and effective expiry (the earlier of open-vial and manufacturer expiry), and warns you as a lot approaches its usable limit.
Does this satisfy NABL 112A?
QCnomics produces the lot-to-lot comparison and verdict with the supporting data and CAPA, which is the evidence assessors examine for NABL 112/112A and ISO 15189:2022.
Clinical-grade internal quality control and ISO 15189:2022 compliance in one platform.
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