QMS · QUALITY EVENTS

Quality events shouldn't run your week.

NCs pile up. CAPAs run overdue. Auditors come asking. With Syneris, every event is connected to the records that actually explain it — equipment, suppliers, training, documents — and Iris helps you investigate deeper without going slower. You stay in control.

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✦ CAPA-000043
Sterilization Cycle Deviation
UNDER INVESTIGATION
QE NC-000119
Sterilization NC
21d open · pattern
EQUIP AC-04
Sensor calibration
12d overdue
AUDIT Q3-2025
PM scheduling
prior finding
DOC SOP-MFG-108
SOP revision
no holiday clause
SUPP Cole-Parmer
Supplier history
2 prior SCARs
TRAIN
Operator training
67% complete
CONNECTED BY DESIGN
IRIS HELPS YOU SEE
WHAT YOU GET

Less time on the form. More time on the fix.

Most quality teams spend more time formatting paperwork than doing the actual work. Syneris handles the structure — gated workflows, e-signatures, audit trails — so you can focus on what actually matters.

● CORE

Every stage. Every event type. Gated.

NC, CAPA & SCAR workflows
Each event type with its own gated, multi-stage workflow. Approval-gated by design.
Stage approvals & e-signatures
Verifiers and approvers per stage. 21 CFR Part 11 compliant signatures, full audit trail.
Cross-record links
Connect events to the records that explain them — equipment, suppliers, documents, training. When an auditor asks "why," the trail's already there.
✦ AI-POWERED

Iris on every field, every stage.

Guided root cause
Iris helps you investigate deeper, surfacing patterns and pulling related records you'd otherwise have to chase.
AI Rewrite on every field
Problem statements, risk justifications, effectiveness criteria, closure summaries — Iris drafts, you refine.
Effectiveness verification
Compare actual outcomes against your defined success criteria. Iris flags recurrence and helps document the evidence.
★ FLAGSHIP CAPABILITY

Root cause analysis, with the full picture.

The cause of an NC usually lives outside the NC — in equipment records, supplier history, recent SOP changes, or training gaps. With every record connected and Iris helping you navigate them, the full context is right there when you need it.

✦ Six Sigma–grade methodology
Iris guides 5-Why, Fishbone, Is/Is-Not, and Pareto analysis where each fits — bringing structured rigor to investigations that otherwise default to free-text fields.
✦ See the patterns across events
When the same sensor type fails in 3 NCs and 2 SCARs over 90 days, that connection should be obvious. Iris helps you spot it.
✦ Pull context from every related record
Equipment calibration, supplier performance, recent SOP revisions, operator training — all surfaced in the investigation, not buried in other modules.
✦ Draft findings, you refine
Iris drafts the writeup based on the evidence. You review, edit, and approve — the language is yours, the analysis is defensible.
ISHIKAWA · 6M FISHBONE
IRIS GUIDED
MAN
people
Operator coverage gap
Training 67% complete
Holiday handoff missing
MACHINE
equipment
Sensor AC-04 drift
Calibration 12d overdue
Autoclave PM lapsed
METHOD
procedure
SOP-MFG-108 revised
No holiday clause
PM scheduling rule
MATERIAL
supplier
Cole-Parmer · 2 SCARs
Sensor lot QC-2024-08
Vendor reliability ↓
MEASUREMENT
verification
Temp drift undetected
Cycle log gap (11min)
Audit-Q3 prior finding
MOTHER NATURE
environment
Holiday period
Reduced staffing
Facility temp stable ✓
✦ PROBLEM
Sterilization Cycle Deviation
CAPA-000043

Stop firefighting. Start fixing.

Show us your oldest open CAPA — we'll show you what an investigation looks like when every record is connected and Iris is helping you dig.

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