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

Cloud QC Software for CLIA Labs

What it is: Cloud QC software is laboratory quality control software delivered as a hosted web service (software as a service, or SaaS). Users reach it in a browser, the vendor runs the servers and updates, and QC data is stored off site. It can be a standalone QC system, a peer comparison program or a compliance platform with a QC module; "cloud" describes how the product is delivered, not what it does.

Cloud QC software lets a lab chart controls, review Westgard flags and sign off QC from any approved device and site, without installing software on bench PCs. For a CLIA lab the questions are practical: can you still show complete, retrievable QC records for at least two years, who can change them, how review is recorded, and how the cloud tool connects to the instruments and to the rest of your compliance records.

Cloud vs. installed QC software

Installed (on-premises)Cloud / SaaS
Where it runsLab or hospital servers and PCsVendor-hosted, reached in a browser
UpdatesScheduled by local ITDelivered by the vendor
Multi-site accessNeeds network setup between sitesAny authorized user with internet access
Instrument dataOften local interfaces or middlewareUpload, connector or manual entry, varies by product
Upfront costLicenses and hardwareUsually a subscription
DependenceOn local ITOn internet access and the vendor

Neither model changes what CLIA requires. Both have to produce the same records.

Examples of cloud QC tools in the market

These are described from each vendor's public pages, in no particular order, and are not endorsements. myLabCompliance has no affiliation or integration with them.

myLabCompliance is also a cloud product. Its home page describes it as a cloud-based solution with secure cloud hosting, so users reach compliance data from anywhere they are authorized. Its QC module sits inside a CLIA compliance platform rather than a manufacturer peer program.

What CLIA requires of QC records, whatever the hosting

CLIA is technology-neutral. The rules that matter most for a cloud QC decision are:

Labs that use an Individualized Quality Control Plan (IQCP) also need a risk assessment, a QC plan and quality assessment, as CMS explains in its IQCP workbook. The software should hold or link those documents.

A cloud QC vendor checklist for CLIA labs

Data and records

QC function

Connections

Access and security

How myLabCompliance handles QC in the cloud

Per its public QC software page, multi-site page and home page:

Its public pages do not describe interlaboratory peer comparison, Sigma metric calculation or a built-in analyzer interface. The Reference / High-Volume plan lists custom workflow automation and API integrations; confirm scope in a demo. See pricing for plan details.

Cloud QC for waived and point-of-care testing

Waived and point-of-care tests are where paper QC logs survive longest. Glucose meters, urine dipsticks, rapid strep, pregnancy and coagulation devices are often spread across clinics, nursing units and offices, and their QC is recorded on clipboards that a reviewer only sees weeks later. For waived tests, CLIA requires the lab to follow the manufacturer's instructions, which often include control testing at set intervals, with each new lot or shipment, and after training or troubleshooting. For moderate-complexity point-of-care tests, the control procedure rules in 42 CFR 493.1256 apply.

A cloud tool helps because each site can record QC on the day it is run and the reviewer can see missed or failed QC without traveling. When choosing one, check that it can schedule QC by device and site, record lot numbers and expirations for controls and test kits, and flag missed QC as well as failed QC. In myLabCompliance, QC schedules, control lot management and inventory records for lot numbers and expirations cover those needs, and waived test setup is described on its multi-site page.

Moving QC to a cloud tool without losing history

myLabCompliance onboarding, per its QC page, covers configuring QC materials, package inserts, schedules, frequencies, levels, lots and acceptance criteria to match how the lab already runs QC.

Who benefits most from cloud QC

Cloud QC tends to help labs where the QC reviewer is not always on site: physician office labs and clinic groups served by a technical consultant, multi-site networks with one quality lead, urgent care chains and labs with heavy point-of-care testing. In each case the value is that review, sign-off and corrective action can happen from wherever the responsible person is, with an audit trail showing when.

Large hospital cores with deep LIS QC modules may still choose to keep QC data in the LIS and use a cloud platform for the records around it. Our comparison of LIMS QC modules and dedicated systems covers that split, and our LIS vs. LIMS quality control guide explains why clinical QC and manufacturing QC start from different records.

See myLabCompliance's cloud QC workflow with your own control materials and schedules.

Book a myLabCompliance demo

FAQs

What is cloud QC software?

Lab quality control software delivered as a hosted web service. Users work in a browser, and the vendor runs the servers. It can be a standalone QC tool, a peer program or a compliance platform with QC.

Is cloud QC software allowed under CLIA?

CLIA does not restrict where records are hosted. 42 CFR 493 requires complete QC documentation, corrective action records, retention for at least two years and availability to surveyors. A cloud tool must support those.

Is myLabCompliance cloud-based?

Yes. Its home page describes a cloud-based solution with secure cloud hosting, used through a web browser.

Does cloud QC software connect to analyzers?

Some products upload data from instruments, middleware or the LIS. myLabCompliance's public pages do not describe a built-in analyzer interface; its Reference / High-Volume plan lists API integrations.

What happens to our QC history if we change vendors?

Export it before the contract ends and keep it for at least the two years required by 42 CFR 493.1105, or longer if your state or accreditor requires.

Can a technical consultant review QC remotely?

In a cloud tool, yes, if they have an account. myLabCompliance describes technical consultant dashboards and monthly report approval with e-signatures.

Does cloud QC replace a peer comparison program?

Not necessarily. Many cloud tools, including myLabCompliance, do not include manufacturer peer data. Labs can keep a peer program and file its reports.

Can cloud QC software track QC for waived tests?

Yes, if it can schedule QC by device and site and record lots and expirations. Waived test QC must follow the manufacturer's instructions; a cloud tool makes missed or failed QC visible to the reviewer sooner.

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.