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 runs | Lab or hospital servers and PCs | Vendor-hosted, reached in a browser |
| Updates | Scheduled by local IT | Delivered by the vendor |
| Multi-site access | Needs network setup between sites | Any authorized user with internet access |
| Instrument data | Often local interfaces or middleware | Upload, connector or manual entry, varies by product |
| Upfront cost | Licenses and hardware | Usually a subscription |
| Dependence | On local IT | On 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.
- InterQC describes itself as a cloud, real-time application for quality control and regulatory compliance management, with real-time statistics, internal and external comparisons, user-set ranges and rules, dashboards, reports, an audit trail and corrective and preventive action records.
- Thermo Fisher LabLink xL WEB is described as an online interlaboratory peer comparison program, part of the LabLink xL family that also lists automated data transfer and multi-site QC management.
- Bio-Rad Unity Real Time is offered in installed and online forms, and Bio-Rad's Unity Next is a web-based peer comparison tool with instant peer reports.
- ASTM Insight SQC is a cloud-based SQC platform designed in conformance with ASTM D6299 for fuel and biofuel labs. It is not aimed at CLIA clinical labs, but it shows how cloud SPC is used in other regulated testing.
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:
- 42 CFR 493.1256: document all control procedures; establish or verify acceptability criteria for each control lot; confirm controls are acceptable before patient results are reported.
- 42 CFR 493.1282: document corrective action, including evaluating patient results back to the last acceptable run.
- 42 CFR 493.1105: keep QC records for at least two years. If you leave a cloud vendor, you still need those records.
- 42 CFR 493.1251: keep a procedure manual that describes control procedures; if the cloud tool is how QC is done, the procedure should say so.
- 42 CFR 493.1773: during a survey the lab must make records available to the surveyor. A cloud tool must let you retrieve them quickly, even if the person who usually runs it is off.
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
- Can you export all QC data, charts, comments and corrective actions in a readable format, at any time and when the contract ends?
- How long does the vendor keep data, and does that cover at least two years plus any state or accreditor requirement?
- Is there an audit trail showing who entered, edited, excluded or reviewed each result, and when?
- Can a run be excluded from charts without deleting it from the log?
QC function
- Which rules are available, and can they be set per test and level?
- How are targets and SDs set for a new control lot?
- Is peer comparison included, and is it tied to one manufacturer's controls?
- Can QC for waived and point-of-care tests be scheduled, not only interfaced analyzers?
Connections
- How do results get in: manual entry, file upload, middleware or LIS?
- Who maintains that connection, and what happens if it fails mid-shift?
- Can QC failures be linked to the staff member, procedure version and instrument record involved?
Access and security
- Is access role-based, and can you remove a departing user the same day?
- Does the vendor sign a business associate agreement if any patient information could be stored?
- What uptime and support terms are written into the contract?
How myLabCompliance handles QC in the cloud
Per its public QC software page, multi-site page and home page:
- Browser-based, cloud-hosted software; nothing to install on bench PCs.
- QC scheduling, package insert records, QC levels, target means, high and low limits, units, lot numbers and expirations.
- Levey-Jennings charts with multiple levels, CSV export and PDF-oriented reports.
- Westgard rule violation detection and QC failure records with root cause, corrective action and resolution notes.
- Excluding a documented run from Levey-Jennings reports while keeping the QC log row.
- IQCP workflows, plus document control with e-signatures, competency, equipment, PT and validation records.
- Organization-scoped records by site, network dashboards, audit trails and technical consultant and lab director sign-off.
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
- Freeze a cutover date per test system and write it into the QC procedure.
- Export the old history (charts, statistics, rule settings, corrective actions) and file it so the last two years remain retrievable.
- Rebuild setup carefully: control materials, levels, lots, targets, SDs, rules and schedules. Check them against the last approved values, not memory.
- Run in parallel for a short period if staffing allows, and compare flags.
- Train and assess staff on the new workflow, and record it as part of competency.
- Have the director approve the revised procedure before go-live.
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.
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
- eCFR 42 CFR 493.1256 Control procedures
- eCFR 42 CFR 493.1282 Corrective actions
- eCFR 42 CFR 493.1105 Record retention
- eCFR 42 CFR 493.1251 Procedure manual
- eCFR 42 CFR 493.15 Laboratories performing waived tests
- eCFR 42 CFR 493.1773 Standard: Basic inspection requirements
- CMS, IQCP workbook (PDF)
- CMS, CLIA program
- InterQC
- Thermo Fisher, LabLink xL
- Thermo Fisher, LabLink xL WEB
- Bio-Rad, Unity Real Time
- Bio-Rad, Unity Next Peer QC
- ASTM, Insight SQC
- myLabCompliance home
- myLabCompliance, QC software
- myLabCompliance, multi-site labs
- myLabCompliance, pricing
Related myLabCompliance pages
- Lab quality control software: types and features
- Lab QC and compliance software buyer's guide
- Lab workflow software guide
- CLIA waived lab software guide
- Moderate complexity CLIA lab software guide
- Molecular CLIA lab software guide
- Standalone QC management software
- QC in a LIMS vs. a dedicated system
- Using myLabCompliance alongside Bio-Rad Unity
- Multi-site lab compliance
- CLIA compliance software
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.