See the trend.Notice the drift.Review the signal.
Every result lands on a control chart for its method, checked against Westgard rules against a locked, signed baseline.
The pattern emerges across results.
Follow one method
Every result on its method's chart
Results plot by method on a Levey-Jennings chart.
How lab SPC works: charts, baselines, rules and printouts
1. Every result on its method's chart
Results plot by method on a Levey-Jennings chart.
See mean, standard deviation and point count.
Compare the spread with what a normal distribution expects.
- List
- All methods with their mean, SD, points and baseline in one list.
Charts use results recorded in V5 Lab & QC.
ASSAY-HPLC-01
Levey-Jennings
- Points (90 days)
- 62
- Mean (x̄)
- 100.2%
- Std dev (σ)
- 0.9
- Within ±1σ
- 69% · expect ~68%
- Window
- 30 · 90 · 180 · 365 days
One chart per method.
2. Limits from a Locked Baseline
Recompute the baseline from a window of results.
Lock it with an e-signature and a reason.
Re-baselining needs its own reason.
- Capability
- Process capability is shown alongside the chart.
Without a locked baseline, Westgard evaluation is off for that method.
Baseline
ASSAY-HPLC-01
- Recompute
- From selected window
- Lock
- E-signature
- Reason
- Required (Part 11)
- Status
- Baseline locked & signed
- Re-baseline
- New reason, new signature
No silent limit changes.
3. Westgard Rules on Every Save
Each result is checked as it is saved.
Mean shifts and out-of-control points are flagged.
Rejection rules open an OOS investigation automatically.
- OOS
- Investigation runs in OOS investigations.
Which rules apply is configured per method by your lab.
New Result
Rule check
- Value
- 97.1%
- z
- −3.4
- Flag
- Beyond ±3σ
- Rule
- Rejection
- Action
- OOS-0019 opened
Evaluated server-side.
4. A Trend Printout for Review
Print the chart, flags and baseline for review.
Use it in periodic trend and management reviews.
Recent points list sits under the chart.
- Review
- Trends support annual product review and management review.
Interpreting a trend is your lab's job; V5 shows the data.
Trend Report
ASSAY-HPLC-01
- Chart
- Levey-Jennings
- Flags
- 1 in window
- Baseline
- Signed 3 Sep
- Distribution
- ±1σ / ±2σ / ±3σ
- Output
- Print PDF
Ready for a trend review.
Where SPC fits
Lab results feed the chart; rejections feed OOS; trends feed review.
- Lab & QCSample plans, results against limits and out-of-spec review.See Lab & QC
- This pageSPC & trendingLevey-Jennings charts and Westgard rules on every result.
- OOS InvestigationsPhase IA, IB and II checklists with signed advancement and closure.See OOS Investigations
- Stability StudiesPull schedules on approved protocols, sent to the sampler.See Stability Studies
AI and SPC & trending
Statistical limits are not AI predictions
Statistical limits are not AI predictions
Ask V5 about chart inputs, specification limits and statistical signals. Calculated SPC measures are distinct from coming-soon process anomaly detection.
Everything in this feature
What lab SPC uses, and which plan each item needs. Compare plans
Levey-Jennings charts
EnterprisePer method, 30–365 day windows.
Signed baselines
EnterpriseLocked with e-signature and reason.
Westgard rules
EnterpriseOn every result.
Automatic OOS on rejection
EnterpriseLinked investigation.
V5 flags the drift. People decide what it means.
Explore the sample records.
Open a sample report to review its contents, supporting references and how the record is built.
UltimateSample register
Lab SPC trend (CSV)
Test & release
- Ultimate
Sample report
Continued Process Verification Report
Quality system
- Ultimate
Sample report
Annual Product Review
Test & release
Quality Evidence & Management Review Buyer Guide
A 19-page guide to quality decisions you can show evidence for: management review, lab results, approved suppliers and customer document sharing.
- Management review: inputs to owned decisions, with a worked quarterly review
- Lab results: specifications, out-of-specification investigation and release boundaries
- Approved suppliers: scope, evidence, expiry and a lapsing certificate
- Customer document sharing: approval, revision, withdrawal and portal evaluation
Plus Connected evidence map, RACI, implementation plan, RFP and scored checklist.
Get the quality evidence guideWe ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy.
UltimateFree buyer guide
Quality Evidence & Management Review Buyer Guide
Straight answers.
What buyers ask us first about Quality & Laboratory.
Does V5 release product automatically?
No. V5 gathers results and records for review, but a person in quality decides and signs the release.
What does the lab side cover?
Lab and QC covers sampling, instruments, methods, results and out-of-spec handling, with LIMS, lab notebook, stability and SPC on top. These are Enterprise features; see Compare details on the pricing page.
Can we use V5 in a validated environment?
For validation-controlled operations, V5's route is Enterprise private cloud with controlled upgrades and IQ/OQ support. Your team still validates V5 for its intended use.
More of the product
Start with one area. Add the rest when you are ready.
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Documents & TrainingExplore 
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Try it with one method you watch closely.
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