---
title: "GMP statistical analysis: SPC, capability, ICH Q2, Q1E | QLogix"
description: "GMP statistics on audited records: control charts with run rules, capability, CPV, ICH Q2 method validation, ICH Q1E shelf life, Gage R&R and DOE, signed as a PDF."
url: https://qlogix.ai/products/statistical-analysis-trending
markdown: https://qlogix.ai/products/statistical-analysis-trending.md
updated: 2026-10-30
publisher: "QLogix (QLogix LLC)"
language: en-US
---

# Statistical analysis for GMP: control charts, capability, CPV, method validation and shelf life
QLogix Analytics is the statistics and trending of the quality system, on the same audited records: control charts with run rules, capability and normality on any series of process or analytical results, hypothesis tests on your data, and Statistical Analysis, a statistics package for the analyses teams otherwise run in desktop statistics packages. In a study you upload or paste the data and ask in plain words or use the menus; the AI chooses the analyses and reads them against the applicable guidance, and a verified engine computes every figure. Studies cover continued process verification and capability, ICH Q2(R2) method validation, ICH Q1E shelf life, measurement systems, designed experiments and clinical designs. The statistical protocol and the report are drafted from the study, and the study is reviewed, approved and signed as a locked PDF.
[Request a demo](https://qlogix.ai/contact)[All products](https://qlogix.ai/products)

## What the module does
- Control charts of individual results with a moving range chart: alert limits at 2 sigma, action limits at 3 sigma, sigma from the average moving range or the standard deviation, and limits from all results, a baseline of the first results or an approved historical mean and sigma; fewer than 20 results for the limits are flagged as preliminary.
- Nelson's eight rules or the four Western Electric rules, each violation named with its points, and specification limits drawn apart from the statistical limits, so being in statistical control and being within specification are reported as separate questions.
- Capability (Cp, Cpk, CPU, CPL, Pp, Ppk, Cpm) with expected parts per million outside specification and the observed count, caveats when the process is out of control, has fewer than 30 results or varies more overall than within; normality by Shapiro-Wilk and Anderson-Darling with the probability plot.
- Hypothesis tests on attached data in Q Intelligence: Welch, paired and one-sample t-tests, Mann-Whitney, one-way ANOVA, Fisher's exact and chi-square, each with the null hypothesis, the statistic, p-value, effect size and confidence interval; the calculations are checked against SciPy.
- Statistical Analysis studies opened blank or from a workflow (continued process verification, capability, attribute monitoring, comparing groups or methods, method validation, stability shelf life, measurement systems, DOE, clinical, reliability), with data from CSV, Excel or PDF or pasted, each file fingerprinted and every dataset kept unedited.
- Q Intelligence as the study's statistician: it chooses the analyses and the assumption checks each needs, the engine runs them on every row, and the AI explains the conclusion, the size of the effect, what a failed assumption means and whether the result meets the guidance, cited by code and section.
- Menus as in a statistics package: descriptive statistics, tolerance intervals and outliers, t-tests, equivalence by two one-sided tests, power and sample size, ANOVA and regression, logistic regression, nonparametrics, reliability and survival, time series, principal components and clustering, each with its method guide.
- Process control for continued process verification: I-MR, Xbar-R, Xbar-S, P, NP, C and U charts, Laney P′ and U′, EWMA and CUSUM for small shifts, limits fixed from a historical baseline or set per stage, trend tests, capability for non-normal data by Box-Cox, lognormal or Weibull, and the process performance report.
- ICH Q2(R2) linearity, accuracy, precision and detection and quantitation limits; ICH Q1E shelf life with poolability at 0.25 and out-of-trend detection; Gage R&R and attribute agreement; acceptance sampling plans; designed experiments with the response optimizer; clinical sample size, randomization, Kaplan-Meier and bioequivalence.

## How it fits the platform
A control chart can be made from a signal review in Signal detection and refreshed from it later, saved for routine trending and pinned to the Q Dashboard. In an investigation, the same hypothesis tests run on each fishbone cause and the result goes into the record. A continued process verification study links to the CPV plan in Validation, and the CPV report reads its capability studies.
Each analysis is read against the guidance a QA statistician cites with it, from FDA Process Validation stage 3 and EU GMP Annex 15 to ICH Q2(R2), ICH Q1E, AIAG MSA and ICH E9, with a link to read it in the regulatory library where it is indexed. A study is a record like any other: every upload, analysis, question, draft and edit is in its hash-chained audit trail, and its locked PDF carries the protocol, each dataset with its source and fingerprint, the analyses, the conversation, the report, the signatures and the audit trail.

## Where people decide
The engine computes every estimate, interval, p-value and index; the AI chooses the analyses, explains them against the guidance and drafts the statistical protocol and the report, and never computes a number. People decide: the author edits the protocol the study follows, takes out an analysis that should not stand with a reason, and routes the study for review and approval, where the signer's electronic signature makes it the statistical record of a decision. A chart flags a point beyond an action limit or a run rule; whether it needs a deviation or an investigation is decided under your SOP.

## Where people decide
- Every figure is the verified engine's; an analysis the engine refuses is reported, not guessed at, and the AI only chooses and explains.
- Datasets are never edited and analyses are never deleted: a corrected file is a new dataset, and an analysis is taken out only with a reason that stays in the audit trail.
- The study is reviewed and approved with electronic signatures; a signed study is frozen, and its locked PDF is the controlled copy.

## Built to
- FDA Process Validation guidance (2011) stage 3 and EU GMP Annex 15
- ICH Q2(R2) and ICH Q14
- ICH Q1E Evaluation of stability data
- ASTM E2587 control charts and ASTM E2281 capability indices
- AIAG Measurement Systems Analysis
- 21 CFR Part 11 and EU GMP Annex 11

## Licensing
Per user per month, on its own or with other modules, ordered by purchase order from the client portal. Every module writes to the same audited records.
[Ask for a quote](https://qlogix.ai/contact)

## Questions about Analytics

### Can QLogix replace a desktop statistics package for GMP work?

Statistical Analysis is built for that: descriptive statistics, hypothesis tests, ANOVA and regression, control charts and capability, Gage R&R, designed experiments, reliability, time series and multivariate analyses, through the menus or a question in plain words. The difference is the record: every upload, analysis, question and draft is in the hash-chained audit trail, and the study is signed and exported as a locked PDF.

### Does the AI calculate the statistics?

No. A verified statistics engine computes every estimate, interval, p-value, coefficient and index; the AI chooses the analyses and explains the results. An analysis the engine refuses, such as one with too few values, is reported rather than guessed at.

### How does it support continued process verification?

The CPV workflow charts the results in lot or time order with the chart that fits the data, runs the tests for special causes, tests for a trend and, once stability is shown, reports capability against the specification. The process performance report gives the control chart, the normality check, the histogram against the specification and Cp, Cpk, Pp and Ppk in one analysis, and the study links to the CPV plan in Validation.

### What is the difference between in statistical control and within specification?

They are different questions, and the chart reports them separately. Statistical control is judged against limits computed from the process's own variation and the run rules; specification compliance is judged against the limits you give. A process can be in control and still produce results outside specification, and the reverse.

### Can it compute the statistics for an ICH Q2(R2) method validation?

Yes. The method validation workflow gives linearity with the slope and intercept and their intervals, residuals and lack-of-fit, accuracy as recovery by level against the acceptance range, repeatability and intermediate precision from a random-effects ANOVA, and detection and quantitation limits as 3.3 σ/S and 10 σ/S, to be confirmed with samples near the limits.

### How is it licensed?

Statistical Analysis is licensed per user per month, on its own or with other modules, ordered by purchase order from the client portal; AI use, including Q Intelligence inside a study, is included in the licence. Control charts saved for routine trending need Generated charts, licensed on its own or in the Quality Plus, Lab and Manufacturing suites, and charts and hypothesis tests in a conversation come with Q Intelligence. There is no card payment or self-serve plan.

## Reading
- [Signal detection in GMP: how control charts with run rules catch a shift or a drift before it becomes a deviationA result inside specification can still be the first point of a shift that ends in an out-of-specification batch three lots later. Control charts with alert limits at two sigma, ac…](https://qlogix.ai/blog/spc-signal-detection-gmp-trending)

## Other modules
- [Agentic QMSeQMS software for pharma, biotech and medical devices: change control, CAPA and controlled documents on one audited record store, AI drafts and signed decisions.](https://qlogix.ai/products/agentic-qms)
- [Root cause investigationAI-assisted deviation, OOS and complaint investigations beside your existing QMS: 5 Whys and fishbone drafted, each cause tested, a robust root cause and CAPA plan.](https://qlogix.ai/products/root-cause-investigation)
- [CAPA managementGMP CAPA software: CAPAs opened from investigations, complaints, audits and changes, an AI review of the plan, evidence for each action and an effectiveness check.](https://qlogix.ai/products/deviation-capa-management)
- [Complaint handlingComplaint handling software for pharma and medical devices: AI triage with quoted evidence, an adverse event check, a route set by QA and the investigation started.](https://qlogix.ai/products/complaint-handling)
- [Batch record reviewBatch record review software that reviews by exception: the AI lists only the exceptions with quotes, QA dispositions each one and signs the release recommendation.](https://qlogix.ai/products/batch-record-review)
- [Batch releaseBatch release software for GMP manufacturing: the batch record, QC results against specification and every quality event checked before QA signs the disposition.](https://qlogix.ai/products/lot-release)
[All 33 product pages](https://qlogix.ai/products)

## More from QLogix

- [Agentic QMS](https://qlogix.ai/products/agentic-qms.md): eQMS software for pharma, biotech and medical devices: change control, CAPA and controlled documents on one audited record store, AI drafts and signed decisions.
- [Root cause investigation](https://qlogix.ai/products/root-cause-investigation.md): AI-assisted deviation, OOS and complaint investigations beside your existing QMS: 5 Whys and fishbone drafted, each cause tested, a robust root cause and CAPA plan.
- [CAPA management](https://qlogix.ai/products/deviation-capa-management.md): GMP CAPA software: CAPAs opened from investigations, complaints, audits and changes, an AI review of the plan, evidence for each action and an effectiveness check.
- [Complaint handling](https://qlogix.ai/products/complaint-handling.md): Complaint handling software for pharma and medical devices: AI triage with quoted evidence, an adverse event check, a route set by QA and the investigation started.
- [Batch record review](https://qlogix.ai/products/batch-record-review.md): Batch record review software that reviews by exception: the AI lists only the exceptions with quotes, QA dispositions each one and signs the release recommendation.
- [Batch release](https://qlogix.ai/products/lot-release.md): Batch release software for GMP manufacturing: the batch record, QC results against specification and every quality event checked before QA signs the disposition.
- [Change management](https://qlogix.ai/products/change-control.md): GMP change management software for document, equipment and facility changes: AI impact and ICH Q9 risk assessment, GMP requirements per item, approval and closure.
- [Document control](https://qlogix.ai/products/document-control.md): Document control software for GMP: AI review of each SOP draft, signed approval on an effective date, read-and-understood training signatures and periodic review.
- [Training](https://qlogix.ai/products/gmp-training-management.md): GMP training management: a training matrix by job function, SOPs read and understood with a Part 11 signature, OJT signed by manager and QA, retraining on change.
- [Risk assessment](https://qlogix.ai/products/quality-risk-management-fmea.md): Quality risk management software for FMEA under ICH Q9(R1): design, process, equipment and CSV templates, RPN thresholds, mitigation tracked to residual risk.
- [Regulatory submissions](https://qlogix.ai/products/regulatory-submissions.md): Regulatory submissions software: post-approval changes screened per market, NDA and BLA sections drafted on an eCTD template, every claim quoted from its source.
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- [QLogix home](https://qlogix.ai/index.md): AI-native GxP operating system for life sciences manufacturers: AI drafts investigations, CAPAs and change assessments from quoted evidence; people review and sign.
- [Services](https://qlogix.ai/services.md): QLogix services that bring the GxP operating system live: digitized records, AI-assisted investigations, connected data, validated AI and agentic workflows.
- [Products](https://qlogix.ai/products.md): QLogix modules on one record store: eQMS, CAPA and deviations, complaints, change and document control, LIMS, ELN, MES and batch records, ERP, CMMS and validation.
- [Blog](https://qlogix.ai/blog.md): QLogix blog: regulatory updates on AI in GxP, FDA and EU guidance explained, and how life sciences quality teams adopt and validate AI.
- [White papers](https://qlogix.ai/whitepapers.md): QLogix white papers: AI investigations, agentic QMS, FMEA, regulatory submissions, complaints, LIMS and CMMS, validation and particulate inspection.
- [Datasheets](https://qlogix.ai/datasheets.md): QLogix product datasheets: a one-page PDF for each module, from complaints, CAPA and change control to LIMS, MES, ERP, validation and Q Intelligence.
- [Request a meeting](https://qlogix.ai/contact.md): Talk to QLogix about the AI-native GxP operating system: AI-drafted investigations, CAPAs and change assessments, implementation, migration and validation.
- [llms.txt: a summary of the site for AI assistants](https://qlogix.ai/llms.txt)
- [Site map](https://qlogix.ai/sitemap.md)

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