Coating thickness reading out of spec on line 2.
PRT-4412 housing · WO-8817 · caught at in-process check
Regulated work, closed on time. Defensible at audit.
Unifize closes the gap between your systems and your teams, so CAPAs, change orders, and design reviews close faster, and close proven.
Find the fit for your work.
Improve a process, evaluate a system, or see Unifize in your regulated world. Pick the one that sounds like you.
By solution
I need to improve a process.
Start with the cross-functional work that is slow, unclear, or difficult to prove.
- QualityCAPA · NC · Audits→
- Supplier ManagementPPAP · SCARs→
- OperationsHolds · Dispositions→
- Product DevelopmentECOs · Design history→
By product
Explore products I am evaluating a system.
Start with the governed record your team needs to run and keep current.
By industry
Show me my regulated world.
Start with your industry: the systems it runs on and the problems it keeps running into.
- Medical DevicesA complaint turns reportable→
- PharmaceuticalsA deviation lands on a batch→
- ChemicalsA formulation change→
- AerospaceA nonconformance on a flight part→
Why regulated work slows down.
The investigation, the review, the decision: that is the work. The chasing, the waiting, and the rebuilding of context around it is the coordination tax, and nothing on your stack measures it.
- QualityCAPAs take 90+ days to close.The investigation is a week of work. The other eleven are spent chasing sign-offs, evidence, and owners.≈19 hrsof coordination per non-conformance, detection to CAPA closureExplore solution
- Document & Records ControlThree copies of one SOP claim to be current.The controlled system says v3.2, a file share holds v3.1, and the line runs a laminated v2.8. The current version depends on where you look.40 minto pull one controlled document under audit pressureExplore solution
- Supplier ManagementSupplier approvals live in email threads.Qualification evidence, PPAP reviews, and SCARs scatter across mailboxes at the organisational boundary.≈14 hrsof coordination per supplier quality issue, incoming to resolvedExplore solution
- Change ControlThe change gets approved. Nobody can replay why.Sign-off happens in email threads and design reviews, so the evidence that was seen and the conditions that were accepted never reach the record.≈30 hrsof coordination per change order, initiation to implementationExplore solution
Coordination tax is why regulated work slows down. Find out what yours costs.
Take the Coordination Tax Assessment →One non-conformance, detection to CAPA closure75 steps
54 of 75 steps are coordination, not quality work.
One platform.
Four governed records.
Start with the system your team needs. Every product runs on the same layer, alongside the systems you already trust.
We know your industry, and where its work gets stuck.
Every industry page starts from the systems you run, the standards you are audited under, and the decisions your teams have to be able to replay.
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
- 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
- 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+
- 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
From the people who stopped paying the coordination tax.
Real customers, on film. Quality directors, engineers, and operators on their own before and after: off legacy systems, live in weeks, closing work faster.
The Will-Burt CompanyTedd Carr, Director of Quality ControlNC closure time down 75% in the first month
Biovation LabsJesse Kolstad, Director of QualityAudit mock recall done in 18 minutes, not 4 hours
Harmonic BionicsMichael Hogan, Mechanical EngineerA design update no longer waits two weeks
Harmonic BionicsClarissa ArcherUp and running in about four weeks, team of five
Harmonic BionicsDenis MachokaManagement review without 15 hours of data pulling
ApplechemWilson Lin90% of the repeat status discussion cut out
Dave AndersonConstructionReaction time on issues 70% better, in smaller groups
Evidence for the next conversation.
The voices, the numbers, and the field notes behind the claims on this page.
Bring the process that hurts most.
A change, an investigation or a supplier issue: we will run it end to end on Unifize, live, and show you where the time is going in a 30-minute walkthrough.