The tax itself · one of your non-conformances
54 of 75 steps
in closing a single non-conformance are coordination, not quality work: notifying, scheduling, re-keying, chasing, rebuilding context. About 19 hours of it per record.
Your work crosses teams.Your systems don’t.
Approvals, changes, and investigations close in email and meetings your systems never see. Unifize makes that work visible, measurable, and faster.
The coordination tax: the work your systems never see.
Chasing sign-offs, rebuilding context, waiting on an inbox. Nothing on your stack measures it.
What the tax turns into
How the tax gets thereDecisions made in reviews and threads are rebuilt weeks later, so teams redo work that was already done.
Source · European Commission · HBR
How the tax gets thereHold, notification, returns, and the submission run under four owners, joined by calls nobody records.
Source · Sedgwick · Recall Index
How the tax gets thereWork in progress ages while holds and dispositions wait in inboxes, with no owner and no due date.
Source · Institute for Supply Management
Your system of record is detached from where the work happens.
Follow one quality defect. Today it crosses six tools. On Unifize it stays on one record.
One defect, six tools, nothing linked.
Logged against the work order in the ERP. Part and lot details are re-keyed into the quality form by hand.
One defect, one record, everything attached.
Raised from the line. Part, work order, and photos attach themselves from the ERP and the phone.
You come for a product. The platform comes with it.
Three bands on one governed foundation. Start with any product and the rest of the platform arrives on day one.
One platform. Every layer connected.
AI suggests affected documents; a person chooses what to add. In beta.
See AI in the workflowQuality brings the assessment, evidence, and sign-off together on CC-2148.
Explore QMSRaise → Assess → Approve → Close.
Platform overview.
Engineered with security and privacy at its core.
- SOC 2 Type II
- GDPR ready
- Zero data training
Your systems stay.
Unifize runs alongside the systems of record and the tools your teams already use. Nothing is ripped out, and only what you agree flows back.
AI that does the coordination work. Your people keep the decisions.
The drafting, the chasing, the looking-up: that is where the coordination tax lives, and that is the work Unifize AI takes first. It is built into each process, not bolted on beside it.
Real teams, on camera, on the record.
Quality leaders, engineers, purchasers and operators on their own before and after: off legacy systems, live in weeks, closing work faster.
Harmonic BionicsDenis MachokaLive in four weeks, where others took almost a year
The Will-Burt CompanyTedd Carr, Director of Quality ControlFive systems consolidated into one platform
Harmonic BionicsMichael Hogan, Mechanical EngineerThe document of record for engineering outputs
Biovation LabsJesse Kolstad, Director of QualityOne approval flow for quotes, formulas and lot release
ApplechemWilson LinIdeation to pre-commercialization about 30% faster
Carol WilsonConstructionMaterial certs found by PO, not a six-week hunt
Harmonic BionicsClarissa ArcherAI suggests, a person verifies and signs off
Audit-ready, whichever standard governs you.
The record you show an auditor is the record the work created.
Electronic records and quality systems
Every industry we serve
- 21 CFR Part 11FDA · US
- EU Annex 11EC · EU
- GAMP 5ISPE · Global
- ISO 9001ISO · Global
- ISO 14001ISO · Global
- ISO 45001ISO · Global
Life sciences
Medical devices · Pharmaceuticals · Contract research · Laboratories
- ISO 13485ISO · Global
- 21 CFR Part 820 (QMSR)FDA · US
- EU MDR 2017/745EC · EU
- EU IVDR 2017/746EC · EU
- ISO 14971ISO · Global
- 21 CFR Parts 210 & 211FDA · US
- EU GMPEC · EU
- ICH Q7ICH · Global
- ICH Q10ICH · Global
- ICH E6 (GCP)ICH · Global
- 21 CFR Part 58 (GLP)FDA · US
- ISO/IEC 17025ISO · Global
- ISO 15189ISO · Global
- CLIACMS · US
Process and consumer
Chemicals · Cosmetics · Food processing · Nutritional supplements
- REACHECHA · EU
- GHSUN · Global
- OSHA PSMOSHA · US
- MoCRAFDA · US
- ISO 22716ISO · Global
- EU Cosmetics Reg. 1223/2009EC · EU
- FSMAFDA · US
- HACCPCodex · Global
- ISO 22000ISO · Global
- FSSC 22000GFSI · Global
- BRCGSGFSI · Global
- SQFGFSI · Global
- 21 CFR Part 111FDA · US
- NSF/ANSI 173NSF · US
Discrete manufacturing
Automotive · Aerospace · Industrial machinery
- IATF 16949IATF · Global
- VDA 6.3VDA · EU
- APQP / PPAPAIAG · Global
- AS9100IAQG · Global
- AS9110IAQG · Global
- AS9120IAQG · Global
- NADCAPPRI · Global
- CE marking · Machinery Reg. 2023/1230EC · EU
- ISO 12100ISO · Global
The questions teams ask before they start.
Anything else, bring it to the walkthrough.
No. Your systems of record stay authoritative and keep their records. Unifize runs alongside them and links to them, so nothing is re-keyed and nothing is ripped out.
One thread. Every decision kept.
Bring the process that costs the most coordination and watch it run end to end on one thread in a 30-minute walkthrough.