Escalated NC-0871 to CAPA. Third seal failure on line 2 this quarter.
Linked to NC-0871 · Batch 22-114 on hold
Solutions · Quality
Your quality system closes the event.It loses the decision.
The judgement behind every deviation, CAPA and audit response lives in email and side channels. Unifize makes the decision part of the record.
The quality manager's home: corrective actions by how long they have been open
Runs wherever quality is regulated
If quality owns it, it has a home here.
The work quality teams actually run, as governed workflows: named owners, evidence attached where the decision happens, a close that stands up in an audit. Start with one; they link as you grow.
The event loop
Something goes wrong, gets investigated, gets closed for good.
- Deviation Management
- Non-conformance and Disposition
- Corrective and Preventive Action
- Customer Complaint Investigation
- Complaint and Event Trending
Release and the lab
Everything between the last test result and product out the door.
- Batch Record Review and Release
- Environmental Monitoring and Facility Control
- Stability and Shelf-Life Management
- Equipment Qualification and Calibration
- Cleaning Validation and Changeover
Risk and validation
Prove it works, and keep it proven as things change.
- Quality Risk Management
- FMEA and Design/Process Risk Analysis
- Validation and Qualification
Suppliers and the field
Quality at the edges: incoming parts, external partners, installed product.
- New Part Approval and First Article Inspection
- Emergency Supplier Authorization
- Contract Manufacturing and CMO Governance
- Product Returns and RMA Processing
- Installation Qualification and Field Commissioning
The work gets done. The record can't prove it.
The failure modes we see inside quality teams. None of them is a missing feature. All of them are decisions that happened off the record.
- Audit-day evidence pull collapses to a manual rebuildHours of exports, screenshots and forwards to rebuild one record.
- Evidence not bound to commit pointsThe decision is on the record. The evidence is in a thread.
- Quality system drift between paper and floorThe SOP passes the audit. The floor runs its own version.
- Disposition decisions live in side channelsThe disposition lands. The reasoning and who agreed do not.
Days of team time, every audit. That waiting is the coordination tax.
Measure your coordination tax →Run the CAPA where the decisions happen.
Most systems track CAPA status. Unifize holds the investigation itself, so root-cause acceptance, committed actions and the effectiveness check seal into a trace an auditor can replay.
One product runs the quality work.
Quality runs in the Quality Management System: its modules share one governed record, from the first event to the sealed close. Run it as your QMS, or alongside the one you keep.
Runs in
Quality Management System
The event backbone: capture, disposition, escalation and verified close on one governed record.
Explore the product →Bring your QMS, or run on ours.
Keep the eQMS that passed your audits. Unifize runs the coordination around it, and the approved outcome goes back with a 21 CFR Part 11 signature. No rip-and-replace, no revalidation.
Proof, to the standard you'd hold us to.
A signed baseline, not a brochure stat, plus the named teams that run quality on Unifize.
- Customer-attested · medical devices41%lower non-conformance coordination cost, measured in year oneMedical-device manufacturer$81,350 a year recovered against a signed $198,150 baselineSigned baseline, anonymized
Harmonic BionicsClarissa ArcherDeviations, NCs and CAPAs linked to supplier, lot and part
Mikala HukkaNutritional SupplementsNon-conformances down from days or weeks to hours
Biovation LabsJesse Kolstad, Director of QualityDecisions that took days or weeks now take minutes
Mikala HukkaNutritional SupplementsOut-of-spec holds cut from a month in quarantine to hours
Biovation LabsJesse Kolstad, Director of QualityAudit findings photographed, given an owner and a due date
Harmonic BionicsDenis MachokaManagement review from dashboards, not 15 hours of analysis
The Will-Burt CompanyTedd Carr, Director of Quality ControlFive separate quality systems consolidated into one
When quality becomes the headline.
Every one of these moments starts a clock, and each routes into a governed workflow, so the response is coordinated on the record it will be judged by.
FDA Form 483 observation issued
Routes to CAPA · Audit Management · owned by VP Quality
FDA Warning Letter received
Routes to CAPA · owned by VP Quality · Executive team
Failed FDA inspection
Routes to Audit Management · owned by Executive team
Close the event. Keep the decision.
Bring one workstream, a CAPA backlog, an audit response or a deviation queue, and see the decision trace on your own work in a 30-minute walkthrough.