Last updated November 2, 2026 · Published by myLabCompliance, one of the products discussed

Standalone QC Management Software for Clinical Labs

What it is: Standalone QC management software is a laboratory application dedicated to internal quality control data. It collects control results, calculates the mean, standard deviation and coefficient of variation for each control level, plots Levey-Jennings charts, applies statistical process control (SPC) rules such as Westgard multirules, and often compares a lab's results with other labs using the same control lot. It runs separately from the laboratory information system (LIS) or LIMS, although many products can receive results from instruments, middleware or the LIS. For labs sorting out the terminology, our LIS vs. LIMS quality control comparison explains how clinical and manufacturing lab QC records differ.

Standalone QC software answers one question very well: is this test system in statistical control right now? Under CLIA, a lab also has to show who reviewed the result, what was done when a rule failed, which patients were evaluated, and whether the people involved were competent. This page explains what standalone QC systems do, which features matter for a CLIA lab, how vendors in this category describe their products, and how myLabCompliance fits for labs that want QC records connected to the rest of their compliance evidence.

The three core jobs of a standalone QC system

Products in this category differ in design, but nearly all of them are built around three jobs.

Statistical process control (SPC). Each control result is stored with its level, lot, test, instrument and time. The software computes running and cumulative statistics (mean, SD, CV), plots the results on a Levey-Jennings chart, and shows how far each point is from the target in SD units.
Rule evaluation. The software checks each run against the lab's chosen rules. In clinical chemistry these are usually Westgard multirules, for example 1_3s, 2_2s, R_4s, 4_1s and 10_x, with 1_2s often used as a warning. Runs that break a rejection rule are flagged so patient results are not released until the problem is resolved.
Peer comparison. Many standalone systems belong to a control manufacturer and pool data from labs that run the same control lot. A lab can see its bias against its peer group and its standard deviation index (SDI). This is a strength of manufacturer programs, because the peer group is defined by the manufacturer's own control lots.

Some products add Sigma metric calculations, measurement uncertainty, rule-selection advisors, automatic data upload from analyzers or middleware, and multi-site dashboards. Those additions vary by vendor and are worth checking one by one.

Westgard rules and Sigma metrics in plain terms

Westgard multirules combine several control rules so a lab can catch real errors without rejecting too many good runs. A single 1_3s rule (one result beyond 3 SD) is good at catching large random errors. A 2_2s rule (two consecutive results beyond 2 SD on the same side) and a 10_x rule (ten consecutive results on one side of the mean) are better at catching shifts and trends. R_4s (a range of more than 4 SD between two controls in the same run) points to random error.

The Sigma metric adds a quality goal to the picture. A common form is Sigma = (TEa% − |Bias%|) / CV%, where TEa is the allowable total error the lab selects, bias usually comes from peer or reference comparison, and CV is the lab's own imprecision. Methods with a high Sigma can often be controlled with simpler rules; methods with a low Sigma need more rules, more controls per run, or method improvement. Our lab quality control software guide walks through the formula in more detail.

Software can calculate both, but it cannot choose the quality goal for you. CLIA leaves the number, type and frequency of controls, and the acceptability criteria, to the laboratory within the minimums in the regulation. The lab director owns that choice.

What CLIA actually requires of QC records

CLIA does not require QC software. It requires outcomes, and those outcomes shape which software features matter. The key sections of 42 CFR Part 493 are:

42 CFR 493.1256 Control procedures. The lab must have control procedures that monitor the accuracy and precision of the complete analytic process. For each quantitative procedure the lab must include two control materials of different concentrations at least once each day patient specimens are assayed, unless an alternative is allowed (for example an IQCP). The lab must establish or verify acceptability criteria for every control lot, results must meet those criteria before patient results are reported, and all control procedures must be documented.
42 CFR 493.1282 Corrective actions. When QC fails, the lab must document corrective action, including an evaluation of patient results back to the last acceptable control run.
42 CFR 493.1281 Comparison of test results, for labs that run the same test on more than one method or instrument.
42 CFR 493.1235 Competency assessment policies for staff, which surveyors often test by asking staff to walk through a QC failure.
42 CFR 493.1105 Record retention. QC records and other analytic systems records must be kept for at least two years.

A standalone QC system covers the statistical part of 493.1256 very well. The record of what happened next, under 493.1282, and the link to personnel, procedures and equipment are usually managed somewhere else. That is the main reason labs look at how QC software connects to the rest of their program.

How vendors in this category describe their products

The products below appear in Google's overview for lab quality control software. Descriptions are taken from each vendor's public pages and are not endorsements or rankings. myLabCompliance has no affiliation or integration with any of them.

Product	Vendor description (public pages)	Typical fit
Bio-Rad Unity Real Time	QC data management with real-time bench and supervisor review, Westgard rules with the optional Westgard Advisor, charts, audit trails and optional QC data upload from an LIS, middleware or instrument. Peer comparison through the Unity Interlaboratory Program and Unity Next.	Clinical labs using Bio-Rad controls that want manufacturer peer data
Thermo Fisher LabLink xL	QC data management with automated transfer from instruments, LIS or middleware, statistical tools including measurement of uncertainty and Six Sigma, digitally signed reports and multi-site management. LabLink xL WEB is described as an online interlaboratory peer comparison program.	Labs using Thermo Scientific controls, multi-site groups
InterQC	Describes itself as a cloud, real-time application for quality control and regulatory compliance management, with internal and external comparisons, user-set ranges and rules, dashboards, reports, an audit trail and corrective and preventive action records.	Labs that want a control-brand-neutral cloud QC tool
ASTM Insight SQC	Described by ASTM as cloud-based statistical quality control built in conformance with ASTM D6299, with auto-scheduling of QC runs, automatic statistics, flagging of warning and out-of-control violations, email notifications and management reports. ASTM announced its acquisition of the platform in December 2025.	Fuel, biofuel and other industrial testing labs, not CLIA clinical labs

The ASTM product is a useful reminder that "lab QC software" covers more than clinical labs. Industrial SPC under ASTM D6299 and clinical QC under CLIA share charting methods, but the regulations, control materials and records are different. A CLIA lab should judge every product against 42 CFR 493.

Where myLabCompliance fits

myLabCompliance is CLIA compliance management software. It is not a manufacturer peer program, and its public pages do not describe interlaboratory peer comparison or Sigma metric calculation. What it does cover, per its QC software page, is the QC workflow a CLIA lab runs every day, connected to the records a surveyor reviews next:

QC scheduling by instrument and test, with group and instrument QC profiles.
Package insert records with QC levels, target means, high and low limits, units, lot numbers and expiration details, plus control lot management.
Levey-Jennings charts with multiple levels, date range and level selection, CSV export and PDF-oriented reports.
Westgard rule violation detection.
QC failure fields for status, retry sessions, attempt sequence, level-specific corrective action, root cause and resolution notes.
The option to exclude a documented QC run from Levey-Jennings reports while keeping the QC log row.
IQCP workflows.

Around QC, the platform holds personnel files and competency assessments, document control with versions and e-signatures, equipment maintenance and calibration, proficiency testing, method validation (linearity, precision, accuracy, AMR), audit trails, and dashboards for technical consultants and lab directors.

Standalone QC vs. a QC-plus-compliance platform

Question	Standalone QC system	myLabCompliance
Levey-Jennings charts and Westgard rules	Core function	Yes
Peer comparison on the same control lot	Common, often tied to the vendor's controls	Not described
Sigma metrics and measurement uncertainty	Offered by some products	Not described; calculate separately and file the result
Automatic capture from analyzers or LIS	Commonly offered	Not described on public pages; the Reference / High-Volume plan lists API integrations, ask in a demo
QC failure investigation and corrective action	Comments or action logs, varies	Yes, with root cause and resolution fields
Personnel, competency, documents, equipment, PT, validation	Not the focus	Yes
Multi-site view	Some products	Yes, organization-scoped records with network dashboards

"Not described" means we did not find the capability on the public page. Check every row with each vendor, including us.

Questions to ask before you buy a standalone QC system

Which control materials does the peer program support? Is it limited to one manufacturer's lots?
How are results entered: manual entry, instrument or middleware upload, or LIS interface? Who maintains that interface?
Can each test have its own rules, or are rules set lab-wide?
How are targets and SDs set for a new lot, and is the crossover data kept?
What does a rule violation record contain? Can it hold patient look-back, root cause and reviewer sign-off, or only a comment?
How are supervisor and director reviews recorded and dated?
How long are records kept, and can they be exported in a readable format for at least the two years CLIA requires?
Does the system hold anything a surveyor asks about next, such as competency, procedures and maintenance, or will those stay elsewhere?

If the last answer is "elsewhere," plan how the two systems will reference each other. Our guide to using myLabCompliance alongside Bio-Rad Unity shows the patterns labs use.

Common mistakes with standalone QC software

Running the software's default rules without writing the chosen rules into the QC procedure.
Leaving manufacturer insert ranges in place long after the lab has enough data to set its own mean and SD.
Treating 1_2s as a rejection rule, which leads to repeated controls and hidden problems.
Logging "repeated, in range" with no root cause, no patient review and no reviewer.
Printing peer reports without signing, dating or acting on them.
Keeping QC in one system and corrective action in a paper binder, with no way to link the two.

See how myLabCompliance connects QC scheduling, Levey-Jennings review and Westgard flags to corrective action, competency and documents.

Book a myLabCompliance demo

FAQs

What is standalone QC management software?

It is software dedicated to laboratory quality control data. It stores control results, calculates statistics, plots Levey-Jennings charts, applies rules such as Westgard multirules and often compares results with peer labs. It runs separately from the LIS or LIMS.

Does CLIA require QC software?

No. 42 CFR 493.1256 requires control procedures, acceptability criteria, review before reporting and documentation. It does not name any product. Paper, spreadsheets or software can all meet it if the records are complete.

How many controls does CLIA require for a quantitative test?

Under 42 CFR 493.1256(d)(3), at least two control materials of different concentrations at least once each day patient specimens are assayed, unless the lab uses an alternative such as an approved IQCP or stricter manufacturer instructions apply.

Is myLabCompliance a standalone QC system?

It is CLIA compliance management software with a QC module. Its public pages list QC scheduling, package insert limits, control lots, Levey-Jennings charts, Westgard rule violation detection, QC failure investigation and IQCP workflows, alongside personnel, documents, equipment, PT and validation.

Does myLabCompliance offer peer comparison or Sigma metrics?

Its public pages do not describe interlaboratory peer comparison or Sigma metric calculation. Labs that want those can keep a manufacturer peer program and file its reports in myLabCompliance document control.

Which Westgard rules should my lab use?

That depends on each method's performance and the quality goal the lab director sets. Sigma metrics are one common way to choose. Write the selected rules and the reason in the QC procedure.

How long must QC records be kept?

42 CFR 493.1105 requires QC records to be kept for at least two years. Some accreditors and states require longer.

Sources

Related myLabCompliance pages

Unity, Unity Real Time and Unity Next are trademarks of Bio-Rad Laboratories, Inc. LabLink xL is a trademark of Thermo Fisher Scientific. InterQC is a trademark of its owner. ASTM Insight SQC is a product of ASTM International. myLabCompliance is independent software and is not affiliated with, endorsed by or integrated with any of these vendors. Vendor details come from each vendor's public pages, linked in the sources, and may change; confirm them with the vendor. This page is educational and is not legal or regulatory advice.