– AI-empowered quality and patient-safety workflows for hospitals
– Link Quality Events → CAPA → Controlled Change → Documents/Training across departments—hosted in-region with committed uptime.
Who it’s for?
- Quality & Patient Safety.
- Risk Management.
- Clinical Governance.
- Nursing Education.
- Pharmacy/Medication Safety.
- Biomedical Engineering.
- HIM/Compliance.
- IT/Clinical Systems.
- Accreditor Liaisons.
What it solves?
- Incident/complaint reports scattered across systems; unclear ownership and handoffs.
- Slow investigations → slow remediation, recurring issues, and weak traceability.
- Policy/SOP version sprawl and training lag after updates.
- Changes to clinical/IT equipment or workflows not tied to documents and training.
- Approval ping-pong and poor visibility for external partners (labs, vendors).
Key capabilities
- In-region data residency (USA • EU • APAC • Middle East • ANZ) and committed uptime.
- Quality Events for incidents/complaints/deviations → triage → investigation → QA/PS review → closure.
- CAPA with root-cause tools and action types: user task • make new document version effective • assign training & require completion; closure dependencies gate CAPA closure.
- Controlled Change for clinical workflows, equipment/IT, and pharmacy processes with impact/risk, stage gates, and closure dependencies (implementation tasks, verifications, linked doc releases/training).
- Document Control & Training — versioned policies/SOPs, e-sign, Read-&-Understood; auto-assign training on release
- AI-empowered (assistive) summaries and suggested fields/checklists (you approve).
- Preliminary Reviewer gate to prevent reject→resubmit loops.
- External Notification Recipient for partners/suppliers (read-only links) to inform relevant stakeholders in real-time and avoid external tool based communication.
- Cross-linking across Quality Events ↔ CAPA ↔ Controlled Change ↔ Documents/Training
- Version and audit diffs, no hard deletion and restore, and configurable labels to adapt to your organisation’s terminology.
Compliance
- Supports hospital quality programs (e.g., accreditation readiness) with Part 11–friendly e-sign (identity, time, meaning/intent) where required, plus immutable, time-stamped audit trails.
- RBAC/least-privilege, retention with restore (no hard deletion), status-gated read-only external access with full notification audit.
- Regional hosting to keep records on the soil of your selected region; uptime commitments documented.
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.
- Incident/Complaint Dossiers with chronology and field-level diffs; jump to linked CAPA/Controlled Change/policy/training.
- Approval Packets for policies/SOPs (signatures, redlines, release notes, R&U/Training matrix).
- Change Evidence Packs for clinical/IT changes—impact/risk → approvals → implementation/verification, with dependency proof.
Outcomes
- Faster remediation and safer care.
- Fewer repeat incidents.
- Clean policy/training evidence.
- Clear cross-department traceability.
