Industries · Laboratories

One QC point breaks 1-3s.Every result it touched is held.

Built for ISO/IEC 17025-accredited testing and calibration labs, where every nonconformance, method deviation, and analyst competency record has to stay traceable, and survive the accreditation surveillance audit.

Built for ISO/IEC 17025-accredited labs

  • ISO/IEC 17025
  • 21 CFR Part 11
  • GLP · 21 CFR 58
  • ALCOA+
  • CLIA / CAP

The decision lives in the thread, not the LIMS result.

Your LIMS records the result. Unifize reconstructs the decision trace around it: the nonconformance, the root cause, the corrective action, and the effectiveness check the assessor asks for.

When the assessor is in the lab, someone reconstructs it.

The reconstruction always lands on someone. Find your seat, and see what you own when the trace has to hold up at the accreditation surveillance audit.

Quality leadership

Every nonconformance and corrective action stays reconstructable.

See the quality solution →

Lab Operations

Method deviations and dispositions move on one accountable thread.

Technical & Method

Method validation, measurement uncertainty, and calibration traceability stay current and linked.

Data Integrity & Compliance

Raw data, audit trails, and electronic signatures are held to ALCOA+.

How it stays validated ↓

Training & Competency

Analyst competency and re-qualification stay current with every method change.

Nonconformance, methods, calibration, competency. One trace.

Each runs with ISO/IEC 17025 built in. Start with the one that costs you most.

Quality

From the nonconforming result to an effectiveness check inside the scope clock.

  • Nonconformance (NC) Management
  • Corrective Action & Effectiveness
  • Method Deviation Management
  • Internal Audit
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Method Development & Validation

Validation evidence, uncertainty and issued results held with the scope they support, down to the reports a drift reached.

  • Method Validation
  • Proficiency Testing / Inter-lab

Equipment & Calibration

Out-of-tolerance found, affected results traced and held on one record.

  • Equipment Calibration & Maintenance
  • Result Disposition

Training & Competency

Every method change reaches the analysts it touches, before the effective date.

  • Competency & Authorization
  • Training Cascades

Built to sit beside your LIMS, and to survive the accreditation audit that assesses it.

  • Coexistence, not replacement

    Unifize sits alongside the LIMS, ELN, QMS, and calibration systems you already run. The corrective-action workflow lands value without a LIMS integration, and replaces the ungoverned channels where the decision trace goes missing.

  • ALCOA+ and Part 11 by default

    Raw data, audit trails, and electronic signatures are attributable and time-stamped, so the technical record holds to ALCOA+ and, for FDA-regulated work, 21 CFR Part 11, not a reconstruction after the fact.

  • Your assessor's questions, answered directly

    Nonconformance and corrective-action closure, analyst competency, calibration history, and method-validation traceability are walked through with your team, and built to survive the biennial surveillance audit.

The moments that start a clock you don't control.

Accreditation and statutory deadlines, not internal outcomes. Each one routes to the process that answers it and the team that owns the response.

ISO/IEC 17025 nonconformance at surveillance

Routes to Corrective Action & Effectiveness · owned by Quality

Customer audit removes lab from an approved list

Routes to Corrective Action & Effectiveness · owned by Quality

Method validation traceability gap at audit

Routes to Method Validation · owned by Technical & Method

The cost is real. It just never lands on a line you can see.

Coordination tax, per company per year

$0.6Mto$6M

Paid in chasing, handoffs and rework, one coordination event at a time. No budget line carries it, so nobody owns it. Modeled across the accredited-lab reference segment (3 companies, 24K employees).

Coordination eventWhat’s at risk
  • Nonconformance → corrective actionNC-3092Qualityweeks of cycle time; scope suspension if it ages
  • Method deviation & validationUncertainty re-checkTechnical & Methoda traceability gap at assessment
  • Analyst competency on method changeDaily BAL-07 checkTraining & Competencyan unauthorized-analyst finding at audit
  • Equipment calibration dispositionBAL-07Quality / Opsrecall of affected results; held reports
  • Data integrity reviewRe-run audit trailData Integrity & Compliancean ALCOA+ finding; lost client work
Every instance, every team. None of it on a budget line.

Incumbents track the result. Unifize reconstructs the decision.

Pick a nonconformance or corrective action you could not replay at the last surveillance audit. We will reconstruct it live.