Every decision made right and made fast.You hear only about the exceptions.

Thousands of decisions a month are made when you are not in the room. Unifize makes sure the right person signs each one, at the speed the risk allows, with the proof there when anyone asks.

See how it works

Available on Microsoft Marketplace

  1. Your launch dates. You hear with eleven days to spare.
  2. Your right to ship. The answer already exists.
  3. Your biggest customers. You called them.
  4. The cost of getting it wrong. Paid for it once.
  5. Nobody gets hurt. Nobody can.
  • Airbus
  • Scout Motors
  • JLL
  • Ground Effects
  • StarFish Medical
  • NeoCoil
  • Jamco
  • Gilat Wavestream
  • The Will-Burt Company
  • Ketjen

Four places. No owner. Rebuilt when asked.

One decision lives in an email, a chat, a file and a tracker. When someone asks who approved it, the answer has to be pieced back together.

On Unifize, the same decision is one record with one owner.

How it works.

Nobody stops to write it up. The record is made as each decision happens, so nothing is typed twice or rebuilt for an audit.

  1. Rules stay current.

    Every procedure, drawing and form has one version in force. When a revision is approved, the old one is superseded everywhere it is used, and the people who work to it are retrained.

    • The old revision is superseded the moment the new one takes effect
    • Training goes to the people the change touches
    • Documents can stay in SharePoint

  2. Decisions record themselves.

    Approvals, answers and evidence are captured where the work happens, in the record's thread and checklist. Nobody re-types a decision into a tracker or an email.

    • A name and a time on every step
    • Approvals signed under 21 CFR Part 11
    • Evidence attached to the record, not to an inbox

  3. The company learns.

    Because every decision is a record, the timings come from ordinary work: how long changes take, where they wait, and which fixes did not hold.

    • Closure time, month by month
    • Where work waits, and on whom
    • Fixes that did not hold, sent to their owner

Where it starts.

One process at a time, from the top down. Quality is the proven place to begin.

Four products. One record underneath.

Quality, documents, manufacturing and product lifecycle, side by side with the systems you already run.

Explore QMS
Explore DMS
Explore MES
Explore PLM

We know where your industry gets stuck.

Pick your industry to see where its decisions break, and the standards they answer to.

Decision trails that stand up to inspectors, sponsors, and assessors.

  • Medical Devices

    A design change that misses one record is a recall.

    Where it bites
    A complaint turns reportable and the 30-day MDR clock starts
    Audited under
    21 CFR 820ISO 13485EU MDR 2017/745
    Explore Medical Devices
  • Pharmaceuticals

    A change approved on a call never reaches change control.

    Where it bites
    A deviation on a batch, with a root cause that holds at inspection
    Audited under
    21 CFR 210/21121 CFR Part 11ICH Q10
    Explore Pharmaceuticals
  • Contract Research Orgs

    Every sponsor can audit you, one study at a time.

    Where it bites
    A protocol deviation, ready to show whichever sponsor asks
    Audited under
    ICH E6(R2) GCP21 CFR Part 11ALCOA+
    Explore Contract Research Orgs
  • Laboratories

    One open nonconformance can suspend your scope in 90 days.

    Where it bites
    An out-of-spec result, closed with an effectiveness check
    Audited under
    ISO/IEC 1702521 CFR Part 11GLP · 21 CFR 58
    Explore Laboratories
Every standard we work under →

Results, in their words.

Real customers, on film. Quality directors, engineers, and operators on their own before and after: off legacy systems, live in weeks, closing work faster.

All customer stories

Evidence for the next conversation.

The voices and numbers behind this page.

Customer storiesIn their own words.Watch the stories Case studiesThe backlog, the fix, the result.Read the case studies BlogField notes for operating leaders.Read the field notes

Bring the process that hurts most.

A change, an investigation, a supplier issue. We run it live on Unifize in 30 minutes.