Best Laboratory Quality Control Software
For the lab director or lab manager choosing a program to run daily QC on nonwaived tests: rule checks, Levey-Jennings charts, control-lot changes, corrective actions and peer data. We read each vendor's user documentation, brochures and product pages beside the control-procedure rules in 42 CFR 493 Subpart K. Quality-management and document-control suites are out of scope.
The verdict by use case
Best overall
Its user guide shows the whole daily loop: Westgard rules set per test, bench and supervisor review, and a corrective action required on every rejected point.
Best for a small lab with nothing to install
Cloud-based with no local install or backups, and Randox states it works with other makers' controls.
Best for multi-site networks
LabLink 360 is built around affiliated-lab oversight, with peer and instrument comparison across sites.
QC duty by QC duty
Each row is a control-procedure duty, or a feature a lab asks for when it buys, with its CLIA cite where one applies. Peer statistics and other makers' controls carry no cite: CLIA requires neither.
- verified against a document
- stated by the vendor
- not stated
Scroll sideways for more vendors
| Requirement | 1Bio-Rad Unity | 2Thermo Scientific LabLink | 3Randox Acusera 24•7 | 4Technopath IAMQC Infinity | 5LigoLab LIS |
|---|---|---|---|---|---|
| AChecks every run against Westgard multirules before patient results go out§ 493.1256(f) | Bio-Rad Unity: verified against a document | Thermo Scientific LabLink: stated by the vendor | Randox Acusera 24•7: stated by the vendor | Technopath IAMQC Infinity: stated by the vendor | LigoLab LIS: stated by the vendor |
| BPlots Levey-Jennings charts for each control level§ 493.1256(c)(2) | Bio-Rad Unity: verified against a document | Thermo Scientific LabLink: stated by the vendor | Randox Acusera 24•7: stated by the vendor | Technopath IAMQC Infinity: stated by the vendor | LigoLab LIS: stated by the vendor |
| CHolds a separate mean and SD for each control lot, so a new lot can run beside the old§ 493.1256(d)(10)(i) | Bio-Rad Unity: verified against a document | Thermo Scientific LabLink: not stated | Randox Acusera 24•7: stated by the vendor | Technopath IAMQC Infinity: not stated | LigoLab LIS: not stated |
| DRecords a corrective action against each rejected run§ 493.1282(b)(2) | Bio-Rad Unity: verified against a document | Thermo Scientific LabLink: stated by the vendor | Randox Acusera 24•7: not stated | Technopath IAMQC Infinity: stated by the vendor | LigoLab LIS: not stated |
| ELogs bench and supervisor review of QC data§ 493.1289(c) | Bio-Rad Unity: verified against a document | Thermo Scientific LabLink: stated by the vendor | Randox Acusera 24•7: stated by the vendor | Technopath IAMQC Infinity: stated by the vendor | LigoLab LIS: not stated |
| FPulls QC results from analyzers, the LIS or middleware without retyping§ 493.1256(g) | Bio-Rad Unity: verified against a document | Thermo Scientific LabLink: stated by the vendor | Randox Acusera 24•7: stated by the vendor | Technopath IAMQC Infinity: stated by the vendor | LigoLab LIS: stated by the vendor |
| GCompares the same test across instruments or sites§ 493.1281(a) | Bio-Rad Unity: not stated | Thermo Scientific LabLink: stated by the vendor | Randox Acusera 24•7: stated by the vendor | Technopath IAMQC Infinity: stated by the vendor | LigoLab LIS: not stated |
| HShows peer-group statistics for the same control lot | Bio-Rad Unity: verified against a document | Thermo Scientific LabLink: stated by the vendor | Randox Acusera 24•7: stated by the vendor | Technopath IAMQC Infinity: stated by the vendor | LigoLab LIS: not stated |
| IAccepts control lots from other manufacturers | Bio-Rad Unity: verified against a document | Thermo Scientific LabLink: not stated | Randox Acusera 24•7: stated by the vendor | Technopath IAMQC Infinity: not stated | LigoLab LIS: not stated |
| JKeeps an audit trail of QC data and its edits for the record§ 493.1105(a)(3) | Bio-Rad Unity: not stated | Thermo Scientific LabLink: stated by the vendor | Randox Acusera 24•7: stated by the vendor | Technopath IAMQC Infinity: stated by the vendor | LigoLab LIS: stated by the vendor |
Program by program
Bio-Rad UnityColumn 1
What it is
Bio-Rad's QC data management family: UnityWeb at entry level, Unity Real Time for full daily QC review, and the Unity Interlaboratory Program for peer reports. UnityConnect pulls QC results off the analyzer feed.
Who it fits
A lab that already runs Bio-Rad controls and wants rule setup, bench and supervisor review and corrective-action entry in one documented workflow. Peer reports cover Bio-Rad control lots only.
What the QC rules ask, and whether it meets it
AChecks every run against Westgard multirules before patient results go out
§ 493.1256(f) verified, source
BPlots Levey-Jennings charts for each control level
§ 493.1256(c)(2) verified, source
CHolds a separate mean and SD for each control lot, so a new lot can run beside the old
§ 493.1256(d)(10)(i) verified, source
DRecords a corrective action against each rejected run
§ 493.1282(b)(2) verified, source
ELogs bench and supervisor review of QC data
§ 493.1289(c) verified, source
FPulls QC results from analyzers, the LIS or middleware without retyping
§ 493.1256(g) verified, source
GCompares the same test across instruments or sites
§ 493.1281(a) not stated; check with the vendor
HShows peer-group statistics for the same control lot
verified, source
IAccepts control lots from other manufacturers
verified, source
JKeeps an audit trail of QC data and its edits for the record
§ 493.1105(a)(3) not stated; check with the vendor
Thermo Scientific LabLinkColumn 2
What it is
Thermo Fisher's QC software for its MAS controls: LabLink 360, a dashboard release, alongside the older LabLink xL. Both offer peer comparison and an auto-connectivity add-on for hands-free QC transfer.
Who it fits
A lab on MAS controls, or a network of affiliated labs that wants one place to compare instruments and sites. Ask which product, 360 or xL, your account will be on.
What the QC rules ask, and whether it meets it
AChecks every run against Westgard multirules before patient results go out
§ 493.1256(f) stated, vendor page; check with the vendor
BPlots Levey-Jennings charts for each control level
§ 493.1256(c)(2) stated, vendor page; check with the vendor
CHolds a separate mean and SD for each control lot, so a new lot can run beside the old
§ 493.1256(d)(10)(i) not stated; check with the vendor
DRecords a corrective action against each rejected run
§ 493.1282(b)(2) stated, vendor page; check with the vendor
ELogs bench and supervisor review of QC data
§ 493.1289(c) stated, vendor page; check with the vendor
FPulls QC results from analyzers, the LIS or middleware without retyping
§ 493.1256(g) stated, vendor page; check with the vendor
GCompares the same test across instruments or sites
§ 493.1281(a) stated, vendor page; check with the vendor
HShows peer-group statistics for the same control lot
stated, vendor page; check with the vendor
IAccepts control lots from other manufacturers
not stated; check with the vendor
JKeeps an audit trail of QC data and its edits for the record
§ 493.1105(a)(3) stated, vendor page; check with the vendor
Randox Acusera 24•7Column 3
What it is
Randox's cloud QC data management and peer-group software, built to sit beside its Acusera third-party controls. Live peer statistics, Levey-Jennings and histogram charts, and an optional Connect module for LIS or middleware upload.
Who it fits
A small lab that wants nothing installed on site and may keep controls from more than one maker. Randox says its internal functions work with any manufacturer's QC material.
What the QC rules ask, and whether it meets it
AChecks every run against Westgard multirules before patient results go out
§ 493.1256(f) stated, vendor page; check with the vendor
BPlots Levey-Jennings charts for each control level
§ 493.1256(c)(2) stated, vendor page; check with the vendor
CHolds a separate mean and SD for each control lot, so a new lot can run beside the old
§ 493.1256(d)(10)(i) stated, vendor page; check with the vendor
DRecords a corrective action against each rejected run
§ 493.1282(b)(2) not stated; check with the vendor
ELogs bench and supervisor review of QC data
§ 493.1289(c) stated, vendor page; check with the vendor
FPulls QC results from analyzers, the LIS or middleware without retyping
§ 493.1256(g) stated, vendor page; check with the vendor
GCompares the same test across instruments or sites
§ 493.1281(a) stated, vendor page; check with the vendor
HShows peer-group statistics for the same control lot
stated, vendor page; check with the vendor
IAccepts control lots from other manufacturers
stated, vendor page; check with the vendor
JKeeps an audit trail of QC data and its edits for the record
§ 493.1105(a)(3) stated, vendor page; check with the vendor
Technopath IAMQC InfinityColumn 4
What it is
Technopath's web-based QC data management service, designed to complement its Multichem controls. IAMQC Peer adds real-time peer comparison and IAMQC Transfer connects the LIS, middleware and analyzers.
Who it fits
A lab that wants Sigma-based rule suggestions, an action log for failed QC and technologist and supervisor sign-off, without running a local server.
What the QC rules ask, and whether it meets it
AChecks every run against Westgard multirules before patient results go out
§ 493.1256(f) stated, vendor page; check with the vendor
BPlots Levey-Jennings charts for each control level
§ 493.1256(c)(2) stated, vendor page; check with the vendor
CHolds a separate mean and SD for each control lot, so a new lot can run beside the old
§ 493.1256(d)(10)(i) not stated; check with the vendor
DRecords a corrective action against each rejected run
§ 493.1282(b)(2) stated, vendor page; check with the vendor
ELogs bench and supervisor review of QC data
§ 493.1289(c) stated, vendor page; check with the vendor
FPulls QC results from analyzers, the LIS or middleware without retyping
§ 493.1256(g) stated, vendor page; check with the vendor
GCompares the same test across instruments or sites
§ 493.1281(a) stated, vendor page; check with the vendor
HShows peer-group statistics for the same control lot
stated, vendor page; check with the vendor
IAccepts control lots from other manufacturers
not stated; check with the vendor
JKeeps an audit trail of QC data and its edits for the record
§ 493.1105(a)(3) stated, vendor page; check with the vendor
LigoLab LISColumn 5
What it is
A laboratory information system whose QC functions sit inside the LIS itself: Levey-Jennings charts, Westgard rules and QC captured from the instrument interface, kept with the rest of the lab's records.
Who it fits
A lab choosing an LIS anyway that would rather not run a second QC program. Ask for a demo of the QC screens on your own analyzers before you count on them.
What the QC rules ask, and whether it meets it
AChecks every run against Westgard multirules before patient results go out
§ 493.1256(f) stated, vendor page; check with the vendor
BPlots Levey-Jennings charts for each control level
§ 493.1256(c)(2) stated, vendor page; check with the vendor
CHolds a separate mean and SD for each control lot, so a new lot can run beside the old
§ 493.1256(d)(10)(i) not stated; check with the vendor
DRecords a corrective action against each rejected run
§ 493.1282(b)(2) not stated; check with the vendor
ELogs bench and supervisor review of QC data
§ 493.1289(c) not stated; check with the vendor
FPulls QC results from analyzers, the LIS or middleware without retyping
§ 493.1256(g) stated, vendor page; check with the vendor
GCompares the same test across instruments or sites
§ 493.1281(a) not stated; check with the vendor
HShows peer-group statistics for the same control lot
not stated; check with the vendor
IAccepts control lots from other manufacturers
not stated; check with the vendor
JKeeps an audit trail of QC data and its edits for the record
§ 493.1105(a)(3) stated, vendor page; check with the vendor
What CLIA asks of a QC record, software or not
2 levels
Control materials of different concentrations, at least once each day patient specimens are assayed (quantitative tests)
Twice a year
Compare results when one test runs on more than one instrument, method or site
No CLIA section names a software product. The duties are the lab's: control results must meet the lab's criteria for acceptability “before reporting patient test results” (§ 493.1256(f)), the lab must “document all control procedures performed” ((g)), and quantitative controls need a mean and SD defined “for each batch and lot number” ((d)(10)(i)). A paper Levey-Jennings chart taped above the analyzer can meet every one of them. Software earns its place when the paper version starts to slip: three analyzers, two shifts, a director who signs off once a month.
The record that most often goes missing is the one after a failure. When controls fail, CLIA asks for more than a rerun:
The rule itself (§ 493.1282(b)(2)): “All patient test results obtained in the unacceptable test run and since the last acceptable test run must be evaluated to determine if patient test results have been adversely affected.”
Takeaway
The Westgard rules you will be asked to switch on
Every product here lets you pick rules test by test. These are the six from Westgard's multirule procedure, as Westgard QC defines them (and Westgard rules explained, rule by rule). Turning all of them on for every analyte is the usual first-week mistake: false rejections pile up and the bench learns to click past them.
| Rule | What it flags | How it is used |
|---|---|---|
| 1-2s | One control result beyond the mean ± 2 SD | Warning only in the classic multirule: look at the other rules before you accept the run |
| 1-3s | One control result beyond the mean ± 3 SD | Reject; usually random error |
| 2-2s | Two consecutive results beyond the same 2 SD limit | Reject; points to systematic error |
| R-4s | One result above +2 SD and another below −2 SD in the same group | Reject; read within the run only, never across runs |
| 4-1s | Four consecutive results beyond the same 1 SD limit | Reject; a shift building up |
| 10x | Ten consecutive results on one side of the mean | Reject; a shift (8x and 12x are variants) |
The rules run on N, the number of control results per run. With the two levels CLIA asks for on a quantitative test, Westgard notes the rules are usually used with Ns of 2 or 4: two control materials measured once or twice each. Which rules you keep is a written decision in your QC procedure, and the software only enforces it. Try the rules on your own data in our Levey-Jennings chart maker.
Switching control lots without a blind month
Lot crossover is where QC software saves the most bench time, and where a bad setup hides the most risk. CLIA wants a mean and SD “for each batch and lot number” of a quantitative control (§ 493.1256(d)(10)(i)). For an assayed control you may use the stated value if it is for your method and instrument and you verify it ((ii)); for an unassayed control the lab builds its own figures “over time”, testing it beside control material that already has them ((iii)).
In practice that means running the new lot alongside the old one before the old one runs out, then giving the new lot its own target values. Bio-Rad's Unity Real Time guide shows the mechanics most products share: duplicate the old lot so tests, levels and rule choices carry over, then either enter a fixed mean and SD or let the software float them. With no fixed values, rule checking waits for a set number of points (twenty by default in Unity).
Takeaway
Peer data is not proficiency testing
Every QC program here sells peer comparison: your control results beside other labs running the same control lot on the same kind of instrument. It is the fastest way to tell an analyzer problem from a bad control lot. It is not a CLIA requirement, and it does not stand in for proficiency testing under Subpart H.
Peer data also depends on whose controls you buy. Bio-Rad's guide is plain about it: interlaboratory reports “are not available for non-Bio-Rad control products”. Ask every vendor whether its peer reports cover controls it did not make, and price the controls and the software together. We read five peer programs side by side in Bio-Rad Unity alternatives.
QC inside the LIS, or a separate QC program
A physician office lab with one chemistry analyzer and a hematology counter often gets by on the QC screens in its LIS: results come in on the same interface as patient results, and the Levey-Jennings chart sits in the same system the inspector already asks to see. What we could not find in an LIS module is peer data; the control makers supply that through their own programs. If you are choosing the LIS at the same time, the LIS comparison for small clinical labs reads those systems against the same CLIA rules.
A separate QC program pays off when one test runs on two analyzers, because CLIA asks you to compare them twice a year (§ 493.1281(a)), or when a director reviews several sites. Some labs run both: the LIS carries patient results, and the QC program carries the statistics, the peer reports and the monthly review. The statistics side has its own section on this site: quality control and PT.
What to make the vendor show you
A demo on the vendor's sample data proves little. Bring a month of your own control results and ask for these on screen.
- Show me an interface for my analyzer, by model, already live at another lab. Not a list of protocols.
- Load one of my control lots that is not yours. What still works, and what goes dark (peer data, usually)?
- Fail a 2-2s on screen. Where do I record the corrective action and the look-back on patient results since the last good run?
- Who can change a mean, an SD or a rule after go-live, and where is that change logged?
- Print the month for my director: Levey-Jennings charts, rule violations, actions and the review sign-off, in one pack.
- If we leave, how do we export two years of QC history in a form an inspector can read?
The CLIA control rules quoted on this page are in 42 CFR § 493.1256.
How this comparison was made
We read Bio-Rad's Unity Real Time quick guide and QC software page, Thermo Fisher's LabLink xL brochure and LabLink 360 pages, Randox's Acusera 24•7 page and brochure, Technopath's IAMQC page and brochure, LigoLab's QC article, and 42 CFR 493 on eCFR, last on .
A filled well means we verified the claim against a document we could read and link: the vendor's own documentation or a regulator's record. An open ring means the vendor says so in its own material, but we found no document to check it against. A blank well means we found nothing either way, which does not prove the product lacks it.
Verdicts are editorial: no vendor can buy a verdict position or displace another vendor. This page carries no prices and no ratings; ask each vendor for a quote and a demo on your own test menu.
Only Bio-Rad published user documentation we could read without an account, so its rows are the only filled wells; the other vendors' rows rest on their brochures and product pages. Instrument-maker middleware and hematology-only QC programs were left out to keep this a roundup of general QC data management.
Questions labs ask
Does CLIA require QC software?
No. CLIA requires the lab to “document all control procedures performed” (§ 493.1256(g)) and to keep those records. A paper log and a hand-drawn Levey-Jennings chart meet the rule if they are complete. Software makes the record harder to lose and the review faster to sign.
Does an IQCP change what the software has to do?
CMS calls an IQCP “an alternative quality control option permitted under CLIA”, built from a risk assessment, a quality control plan and quality assessment. Without one, a lab “must test two levels of external controls on each test system for each day of testing”. The software records whatever frequency your plan sets; the plan itself is a document your director signs. CMS explains the option on its IQCP page, and our IQCP risk assessment worksheet drafts the plan.
How long do QC records have to be kept?
QC and patient test records, instrument printouts included, for “at least 2 years” (§ 493.1105(a)(3)). Check that the software keeps that much history online, or that you can export it in a form you can show an inspector after the contract ends.
Do controls have to be rerun after a reagent change?
Yes, before patient testing resumes, when “a complete change of reagents” is introduced, after major preventive maintenance, or when a critical part is replaced (§ 493.1256(d)(6)). Unity's guide shows an action logged once against an instrument for maintenance or calibration, and LabLink and Acusera 24•7 describe event tracking, so a shift on the chart carries its reason.
What is the difference between UnityWeb and Unity Real Time?
Bio-Rad describes UnityWeb as an “entry-level QC data management solution providing peer comparison and daily QC tools” and Unity Real Time as the expert level that “offers everything from UnityWeb plus provides advanced charts”. Its QC software page lists both. Ask which one your control contract includes.