QC Analysis
Statistical Process Control · Westgard Rules · OOS Detection · Trend Monitoring
Statistical control that works before limits are breached, not after. Replace manual Levey-Jennings charts, spreadsheet-based QC logs, and after-the-fact OOS investigations with a QC program that monitors your data continuously, flags shifts before they become failures, and connects every result to the quality system that governs it.
Rules that run automatically
Westgard rules, custom control limits, and peer-group comparison are configured once and applied to every QC run. No manual chart review. No missed warning signals. Kintavo evaluates every result as it's entered and flags violations before the next patient sample is processed.
OOS events that don't start from scratch
When a result triggers an out-of-specification flag, Kintavo initiates a structured investigation workflow pre-populated with the result, the instrument, the reagent lot, and the operator — so your team is investigating the event, not reconstructing it.
Trends that surface before they become findings
Kintavo monitors QC data across instruments, reagent lots, and time periods to detect drift, bias, and run-length patterns that precede failure. Quality leaders see the signal before the limit is breached — and before an inspector finds a trend your team missed.
A QC failure is not an isolated data point.
A QC failure in Kintavo initiates a deviation, links to CAPA, and surfaces in the compliance dashboard. QC is part of the quality system, not a parallel process.
Westgard warnings before action limits hit.
Kintavo surfaces Westgard warning rule violations and directional trends before results hit action limits — giving your team the opportunity to investigate and intervene before results are in question.
From run to verified result.
QC in Kintavo runs continuously — capturing data, applying rules, surfacing trends, and connecting failures to the quality system.
Capture
QC data captured per run, per analyte, per instrument.
Evaluate
Westgard rules applied. Warning and action limits assessed.
Alert
Notifications fire on warnings before action limits hit.
Trend
Drift detection across runs surfaces problems early.
Resolve
Failures trigger deviations and CAPAs with full linkage.
QC doesn't live alone.
Every QC failure links to the instrument that produced it, the calibration record, the deviation it triggered, and the CAPA that closed it.
Ready to see the full platform working for your organization?
Book a personalized demo. We'll show you Kintavo configured for your regulatory environment and your specific workflows — not a generic product tour.
FAQ Questions & Answers
Q: What statistical QC rules does Kintavo support?
Kintavo supports the full Westgard multirule set — 1₂s, 1₃s, 2₂s, R₄s, 4₁s, 10x — as well as custom control rules defined by your laboratory. Rules can be applied at the analyte level, the instrument level, or across all instruments running the same method. Your QC team configures which rules are warning rules and which are rejection rules, and Kintavo enforces them consistently on every run without manual chart review.
Q: How does Kintavo handle out-of-specification results?
When a QC result triggers a rejection rule, Kintavo flags the run and can be configured to initiate a structured OOS investigation workflow automatically. The investigation record is pre-populated with the result, the instrument, the reagent lot, the calibration status of the instrument at the time of the run, and the operator. Your team documents the investigation, root cause, corrective action, and disposition of affected patient results — all in one traceable record linked back to the original QC event.
Q: Can Kintavo detect trends before a control limit is breached?
Yes. Kintavo monitors QC data continuously for warning-level patterns — systematic bias, gradual drift, run-length violations, and reagent lot-to-lot shifts — that precede an outright rejection. Warning flags appear in the QA dashboard before a limit is breached, giving your team time to investigate and intervene. This is particularly valuable for detecting reagent degradation or instrument drift that would otherwise go unnoticed until a critical OOS event.
Q: How are control limits set and managed?
Control limits can be set from your own laboratory's cumulative mean and standard deviation, from manufacturer-provided ranges, or from peer-group data depending on your accreditation requirements. Limits are stored on the analyte-instrument combination and versioned — so when a new reagent lot is introduced and limits are recalculated, the prior limits and their effective dates are retained in the audit trail. Limit changes require documented justification and approval.
Q: Does Kintavo support peer-group or interlaboratory QC comparison?
Yes. Kintavo supports peer-group comparison programs, allowing your results to be benchmarked against defined peer groups for bias detection and method performance evaluation. This is particularly relevant for laboratories operating under CAP accreditation, where peer comparison is a standard expectation. Results and peer-group statistics are stored on the analyte record and available for proficiency testing review.
Q: How does QC Analysis connect to other modules?
QC results in Kintavo are linked across the platform. An OOS event automatically references the instrument asset record and its current calibration status. Reagent lots can be linked to the QC results produced with them. Deviation records initiated from OOS events carry the full QC context. CAPA records can be initiated from repeat OOS patterns. Equipment Management and QC Analysis work together — when an instrument is flagged as out of service, QC runs on that instrument are automatically flagged for review.
Q: Can we manage multiple instruments running the same method?
Yes. Kintavo supports method-level QC management across multiple instruments. Control charts, rule violations, and trend data can be viewed at the method level — across all instruments running that method — or filtered to a single instrument. This makes it easy to distinguish instrument-specific problems from reagent lot or method-level issues, and to compare performance across sites running the same assay.
Q: Is Kintavo QC Analysis compliant with CAP, CLIA, and ISO 15189 requirements?
Yes. Kintavo's QC module is designed to support the statistical QC documentation requirements of CAP, CLIA, and ISO 15189. This includes defined control rules, documented control limits with their basis, run-by-run QC records, OOS investigation documentation, and trending analysis. The specific implementation is configured by your laboratory team to match your accreditation requirements and QC policy.
Q: Is the QC record 21 CFR Part 11 compliant?
Yes. Every QC result entry, rule evaluation, flag, OOS investigation, and corrective action is captured in a time-stamped, user-attributed audit trail that meets 21 CFR Part 11 and EU Annex 11 requirements. Electronic signatures are required for OOS investigation approval and record closure. The complete QC history for any analyte, instrument, or reagent lot is exportable for inspection or accreditation review in seconds.
Q: What does implementation look like for QC Analysis?
Your implementation lead works with your laboratory QA team to configure analytes, instruments, control materials, control limits, and Westgard rule sets — typically within the first two to three weeks of onboarding. Historical QC data can be migrated from spreadsheets or prior systems to establish baseline trending. Most customers have their QC program live and generating automated rule evaluations within 30 days of kickoff.
Your QC data is telling you something. The question is whether you're hearing it before or after the finding.
Manual Levey-Jennings charts require someone to look at them. Spreadsheet-based QC logs require someone to maintain them. And when an out-of-specification result finally gets flagged, the investigation starts cold — pulling reagent lot numbers, instrument logs, and operator records from three different places while the clock runs on affected samples downstream.
Kintavo QC Analysis gives you a statistical QC program that evaluates every run automatically against your defined rules, flags warning conditions before they become violations, and initiates structured OOS investigations with the relevant context already attached. Your QC data is monitored continuously — not reviewed whenever someone has time — and every result, flag, and investigation is captured in a 21 CFR Part 11 compliant audit trail that holds up under regulatory scrutiny.