Adverse event intake and recall readiness
From a consumer report to a MedWatch draft, and from a recall decision to a reconciled return, on one record.
What it does
A public, tokenized intake endpoint takes a consumer report straight into a triage queue that feeds the QMS, instead of an email that has to be manually re-entered. From there, ERRA supports the reportability decision with a MedWatch 3500A draft; the reporting-clock guidance is decision support, not an enforced deadline, and the record says so.
A controlled recall draws its blast radius from the shipment and lot genealogy already on file, notifies consignees, and tracks RMA returns through to reconciliation.
What's in it
- Public tokenized consumer-intake endpoint feeding the QMS triage queue.
- Adverse event reportability decision support and a MedWatch 3500A draft.
- Controlled recall with blast-radius calculation, consignee notification, RMA returns, and reconciliation.
- Training curricula tied to role requirements, with signed self-attested completions and a compliance rollup.
Keep reading
Continuous attestation starts with a record that can be checked.
They check the sample. We attest to the system.