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Using myLabCompliance Alongside Bio-Rad Unity

Bio-Rad Unity products focus on control data: charts, statistical rules and comparison with peer labs using the same Bio-Rad control lot. A CLIA lab also has to keep personnel files, competency, procedures, equipment logs, proficiency testing and corrective action records. myLabCompliance is CLIA compliance management software that covers those records, plus its own QC workflows with Levey-Jennings charts and Westgard rule detection. Many labs can use both, with a clear rule for which system holds which record.

This page is published by myLabCompliance, an independent software company. It is not a Bio-Rad page, and myLabCompliance is not affiliated with or endorsed by Bio-Rad. For Unity sign-in or software help, use Bio-Rad's QCNet Help Center.

Two kinds of tools, two different jobs

Lab teams sometimes ask whether they need "QC software" or "compliance software." The honest answer is that the two categories overlap only in part.

Bio-Rad Unity is a family of QC data tools. Bio-Rad's Unity Real Time 2 User Guide lists charts and reports, bench and supervisor review, Westgard (SPC) rule settings, lab, lot, test and panel configuration and multi-test data entry. The Unity Interlaboratory Program compares a lab's results with peer labs running the same control lot and posts reports on QCNet. Unity Next Peer QC is described by Bio-Rad as its newer peer comparison tool with instant peer reports.

myLabCompliance describes itself as CLIA compliance management software for technical consultants, lab directors, lab owners and QA teams (mylabcompliance.io). Its QC software page lists QC scheduling, package insert limits, control lot management, Levey-Jennings charts with multiple levels, Westgard rule violation detection, QC failure investigation tracking, root cause and corrective action fields, CSV export and IQCP workflows. The rest of the platform covers personnel and competency, document control, equipment, proficiency testing, validation and survey evidence.

The overlap is QC charting and rule checks. The gap that Unity does not aim to fill is everything around QC that a surveyor also reviews.

What each tool covers

NeedBio-Rad Unity (per Bio-Rad docs)myLabCompliance (per its public pages)
Levey-Jennings charts and SPC/Westgard rulesYesYes
Peer comparison with other labs on the same control lotYes (Unity Interlab, Unity Next)Not described
On-demand peer reports for troubleshootingInstantQC reportsNot described
QC failure investigation, root cause and corrective action fieldsAction logs and commentsYes
Control lot and package insert limitsLot configurationYes
Document control with versions and e-signaturesNot its focusYes
Personnel files and six-element competencyNot its focusYes
Equipment maintenance, calibration, temperature logsNot its focusYes
PT enrollment, results and corrective actionNot its focus (Bio-Rad EQAS is a separate program)Yes
Survey evidence grid across record typesNot its focusYes

"Not described" means we did not find the capability on the vendor's public pages. Confirm details with each vendor.

How data moves between them

myLabCompliance's public pages do not describe a direct import from, or integration with, any Bio-Rad Unity product. Plan on entering QC results in myLabCompliance, or keeping Unity as the QC record and filing exported Unity reports in myLabCompliance as documents. The Reference / High-Volume plan lists custom workflow automation and API integrations; ask during a demo what that would cover for your lab.

That sounds like extra work, and for some labs it is. In practice, labs usually pick one of three patterns.

Pattern 1: Unity for QC, myLabCompliance for everything else

The lab keeps daily QC entry, rules and charts in Unity, and uses peer reports from Unity Interlab or Unity Next. myLabCompliance holds the rest of the program.

This keeps a single QC source of truth in Unity while giving surveyors one place to find connected evidence.

Pattern 2: myLabCompliance for QC, Unity for peer data

The lab enters daily QC in myLabCompliance, using its QC schedules, package insert limits, Levey-Jennings charts and Westgard detection. It keeps a Unity peer program running for comparison with other labs, submitting data to Bio-Rad by whatever method Bio-Rad supports for that lab.

This puts daily QC, investigations and corrective action in the same system as documents, competency and equipment. The cost is that QC data ends up in two places, so the lab must decide which record is official and write that in its QC procedure.

Pattern 3: A defined split during a transition

Some labs move gradually: one department or instrument group at a time. During the transition, write down which tests are charted where, starting on which date. A surveyor will accept two systems; they will not accept confusion about which one is the record.

Setting up Bio-Rad controls in myLabCompliance

If myLabCompliance will chart some or all of your QC, setup follows the same logic you used in Unity, recorded in a different place. myLabCompliance's QC page says onboarding covers configuring QC materials, package inserts, schedules, frequencies, levels, lots and acceptance criteria to match how the lab already runs QC. For a lab using Bio-Rad material, that usually means:

The QC page also describes the ability to exclude a QC run from Levey-Jennings reports while keeping the QC log row, so a documented, explained run does not distort trend review but stays in the record.

Rules that keep a two-system setup clean

IQCP and quality assessment

Labs that use an Individualized Quality Control Plan need risk assessment, a QC plan and ongoing quality assessment. myLabCompliance lists IQCP workflows on its QC page. Unity QC history and peer reports are useful evidence for the risk assessment; export the summaries you rely on and file them with the IQCP so the plan and its evidence sit together. Review them at the interval the plan sets and record the conclusion.

Why the surrounding records matter under CLIA

CLIA QC rules in 42 CFR 493.1256 cover more than charts: acceptability criteria for each control lot, review before reporting, and documentation of all control procedures. Corrective action under 42 CFR 493.1282 must include evaluation of patient results back to the last acceptable run. And 42 CFR 493.1235 requires written competency assessment policies, which surveyors often test by asking the person who handled a QC failure about it. When those records sit in one platform, the connection between a red flag, the person who responded and the procedure they followed is easier to show.

myLabCompliance's accreditation surveys guide covers how to organize evidence from QC, PT, personnel, documents and equipment for a survey.

For multi-site groups, the multi-site page describes records scoped by site, network dashboards and audit trails, and technical consultants approving monthly reports with e-signatures. That fits labs where each site runs its own Bio-Rad lots and Unity account but leadership needs one view of compliance.

See how myLabCompliance would sit next to your current Bio-Rad QC setup.

Book a myLabCompliance demo

FAQs

Does myLabCompliance import data from Bio-Rad Unity?

Its public pages do not describe a Unity import or integration. QC results are entered in myLabCompliance, or Unity reports are exported and filed as documents. The Reference / High-Volume plan lists custom API integrations; ask during a demo.

Is myLabCompliance affiliated with Bio-Rad?

No. myLabCompliance is independent software. It is not a Bio-Rad product and is not endorsed or certified by Bio-Rad.

Does myLabCompliance offer peer comparison like Unity Interlab?

Its public pages do not describe an interlaboratory peer comparison program. Labs that want peer data can keep a peer program and use myLabCompliance for QC workflows and the rest of their compliance records.

Can I keep using Unity Real Time and still use myLabCompliance?

Yes. A common setup keeps QC data in Unity and uses myLabCompliance for documents, competency, equipment, PT, corrective action and survey evidence, with Unity reports filed in document control.

Does myLabCompliance have Levey-Jennings charts and Westgard rules?

Yes. Its QC software page lists Levey-Jennings charts with multiple levels and Westgard rule violation detection.

Which record do surveyors want if we use two systems?

The one your QC procedure names as the system of record. Write that down and keep the other system consistent with it.

Can myLabCompliance hold Bio-Rad control lots and insert limits?

Yes. Its QC pages describe package insert records with QC levels, target means, high and low limits, units, lot numbers and expiration details, plus control lot management.

Does this work for a lab with several sites?

myLabCompliance describes organization-scoped records by site, network-level dashboards and audit trails on its multi-site page. Each site can file its own Unity exports and QC records, and leaders can view them across the network.

Sources

Related myLabCompliance pages

Bio-Rad, Unity, Unity Real Time, UnityWeb, Unity Next, QCNet, InstantQC, Westgard Advisor, EQAS, Lyphochek, Liquichek and InteliQ are trademarks of Bio-Rad Laboratories, Inc. myLabCompliance is independent software and is not affiliated with or endorsed by Bio-Rad. Bio-Rad product details here are taken from Bio-Rad's public pages and help documentation, linked in the sources; check them with Bio-Rad. This page is educational and is not legal or regulatory advice.