Westgard evaluates. The wrong result won't pass.
There's an honest test for whether a system is a real LIMS or a spreadsheet with a login: what it does when the control fails. Here the run stops right there, before the report reaches the client's hands. There are 24 control types, the statistical rules standards recognize, and automatic release blocking, at a level many labs only see in expensive market-leading LIMS. The auditor asks for the control chart, you open it on screen with the σ zones and the 7 rules already evaluated.
The right control for each step, already there.
24 types, field and lab (field and trip blank, duplicate, spike, LCS and LCSD, matrix spike, surrogate, CRM, CCV, CCB, ICV, ICB and more), with frequency configurable per sample, batch, sequence, time or shift.
The system evaluates Westgard and tells you what to do.
The Levey-Jennings control chart comes ready and the 7 Westgard rules (1-2s, 1-3s, 2-2s, R-4s, 4-1s, 10x, 7T) are evaluated on their own. No staring at a chart trying to recall the rule: the system says warning or rejection.
Correct the method before you lose a whole batch.
CUSUM (ISO 7870-4) catches the small, persistent drift Levey-Jennings lets through, and EWMA (ISO 7870-6) reveals the trend by smoothing the noise. You act before the rejection.
An expired control reagent never slips by.
Certified reference materials with lot, validity and certified values, with an automatic alert as they near expiry. Holding times per parameter and matrix, counting from collection, receipt or preservation.
A failed control never becomes a report.
Each rule defines what happens on failure: alert, release block, nonconformity creation or reanalysis. The result is held until it's right.
Control frequency on autopilot.
You set every how-many samples, at which point in the sequence, or on which shift the control kicks in. The system chases it, instead of relying on the analyst to remember to run the blank.
Warning and rejection are different things.
The rule that warns asks for attention; the one that rejects locks. The system separates the two, so a trend signal doesn't stop the run for nothing and a real error doesn't pass as a heads-up.
The control chart tells the method's story.
Points plotted over time show whether the method is stable, drifting or losing precision. You see the problem coming, not only when it blows up.
Why CUSUM and EWMA change the game
Levey-Jennings catches the gross error. The small, stubborn drift that pulls the method week after week usually slips by until it becomes a rejection. That's where the other charts come in.
CUSUM adds up what the eye misses.
It sums the small deviations in the same direction. When the trend persists, CUSUM lights up before Levey-Jennings, and you correct without losing a run.
EWMA clears the noise to show the drift.
It weights recent data more and smooths normal scatter. What's left is the real trend, not the day's up-and-down.
Catching it early is money you don't lose.
Recalibrating the method on drift costs a morning. Reanalyzing the batch after rejection costs the whole batch and the client's deadline.
Frequently asked questions
Does the system really evaluate the 7 Westgard rules on its own?
Yes. The Levey-Jennings chart is calculated and the 7 rules (1-2s, 1-3s, 2-2s, R-4s, 4-1s, 10x, 7T) are evaluated automatically. No memorizing rules or counting points on a chart: the system says warning or rejection.
What's the practical difference of having CUSUM and EWMA?
Levey-Jennings and the Westgard rules catch the large, one-off deviation. CUSUM and EWMA catch the small, persistent drift, the one that pulls the method without failing right away. With them you correct before losing a whole batch.
What happens when a mandatory control fails?
Each rule defines the action on failure: alert, release block, nonconformity creation or reanalysis. When the block is on, the result is held and won't become a report until the control is back in conformance.
Do I have to buy a separate QC module?
No. Westgard with 7 rules, Levey-Jennings, CUSUM, EWMA and CRM expiry control come in the same plan. In many LIMS this is a separate big-lab license; here there's no QC add-on.
Want to see the QMS running with your lab’s routine?
Get through the next audit without burning a weekend night hunting for PDFs. Book a demo and see document control, CAPA and Westgard working with a case similar to your lab's.