quality EVENTS – Customer Complaints/DEVIATION/NCS from Intake to Closure—AI-Assisted, Audit-Ready
Who it’s for?
- Investigators
- QA
- Customer Quality
What it solves?
- Scattered complaint/deviation/NCR information.
- Unclear ownership.
- Slow investigations leading to slow closure/remediation.
- Access for external users based on configured Event status so the complainant is always informed.
- Complaints that vanish after closure.
- Approval ping-pong: avoid reject→resubmit loops with a Preliminary Reviewer gate.
Key capabilities
- Reports: turnaround time, repeat issues, Pareto by cause
- Cross-linking: Quality Event ↔ CAPA ↔ Controlled Change ↔ response Documents
- Audit-trail diffs & filters by user/date/action
- No hard deletion: soft-delete & restore; restorations fully logged
- Configurable labels/roles (statuses, investigator/QA/approver)
- External portal access gated by status (read-only updates for complainants)
- AI Assist: auto generation of 5 Whys based on provided information.
- Built-in Risk Matrix integration ie 3*3, 4*4, 5*5
- Versioning with review/approval workflows and e-sign (meaning/intent)
- Read-and-Understood tracking; auto-assign training on release
- Redlines, change logs, and periodic configurable reminders
- Your terminology, our controls: configurable status & role names.
Compliance
- Approvals with meaning.
- Trails across linked records.
- No hard deletion of records and on demand restoration of deleted records.
- Strong audit trails.
Audit ease
- Time-stamped, immutable audit trails with a clean, side-by-side diff so you can compare any two versions and see who changed what, when, and why.
- Side-by-side version compare.
- Approval Packet export: signatures, redlines, release notes, watermarked print.
- Complaint Dossier export (case/date range) with attachments & AI summary.
- Chronology timeline + field-level diffs; jump to linked CAPA/Controlled Change/Documents.