Operational snapshot
Hospital-facing summary only
1. Intake and watch
Separate watch signals from authoritative AU action
| Signal type | Meaning | Next step |
|---|---|---|
| DRAC / TGA action | Authoritative AU market action trigger | Open AU action case |
| Sponsor notice before AU agreement | Operationally relevant but not yet a binding AU market action | Watch / pre-case + local review |
| FDA / global signal | Early warning / enrichment | Check ARTG + local inventory |
| Hospital incident | Local device event / concern / near miss | Incident case + route decision |
2. Route decision
Support the AU reporting decision, then capture proof
Assess the event
Serious deterioration/death, unusual incident, central route already used, or market-action only.
Store the route record
Chosen route, trigger facts, due date, approver role, and whether submission proof is required.
Capture proof
Store receipt references, supporting files, and approval roles. No direct API claim is made.
Hospital workflow
The core path used in the AU Tier 0–1 demo
Case Intake
Create an AU market action case, incident case, combined case, or manual exception case. Confirm ARTG link, sponsor, device family, urgency, and owner role.
Inventory Matching
Start with CSV import. Confirm affected local assets by model, lot, serial, or software/configuration where relevant. Show affected units by site.
Action Tracker
Assign local actions like quarantine, correction, replacement, continue-use restriction, or communication with due dates and owners.
Evidence Pack
Use the two-zone model: platform-held evidence plus local clinical evidence references only.
Submission Proof
Track ASDER/IRIS, sponsor/manufacturer follow-up, or market-action proof without claiming direct TGA API integration.
Closure Review + Audit Export
Check every affected asset, every required action, and every proof record before verified closure and audit export.
Evidence model
Keep operational proof in-platform while clinical files stay local
Zone A · Platform evidence
Notice record, inventory reconciliation, quarantine proof, correction proof, submission proof, sign-off, and exception record.
Zone B · Local references only
Clinical notes, EHR screenshots, patient-linked files, and follow-up records remain in hospital systems. The platform stores only a local reference and attestation.
What the audit pack contains
Proof that a hospital actually managed the case
Case summary + source provenance
Why the case exists and how it entered the hospital workflow.
Affected-asset list by site
What was found locally and how each asset was handled.
Submission-proof register + closure decision
Stored route record, references, exceptions, and final sign-off state.
Trust and hosting posture
Commercially intelligible trust layer for the AU demo
Demo mode
This environment is synthetic / illustrative. It is not presented as a live deployed hospital system.
Hosting statement
Production hosting, access control, and breach-response posture are defined separately from the demo and should be finalized with counsel and implementation decisions.
Reporting boundary
The platform supports route decision, package preparation, and proof capture. It does not claim direct TGA API submission.