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MoCRA compliance, integrated into your support inbox.
Probata watches your Gorgias support inbox, pre-classifies customer-reported adverse events against the FD&C Act §604(5) seriousness criteria, drafts MedWatch Form 3500A reports, and tracks the §605(b)(1) 15-business-day FDA reporting deadline so you never miss one.
Sign up free, connect Gorgias in two minutes, and AE intake starts running on every new ticket. Registration tracking, label monitoring, substantiation files, and quality-agreement management roll out next.
What's inside
The free tools answer one question. The paid app does it continuously, on every support ticket.
- Gorgias inbox watch. Connect Gorgias once. Every new support ticket gets pre-classified against the §604(5)(A) serious-AE checklist; anything flagged lands in your Probata AE inbox in under a minute.
- Workflow on top of the classifier. Your QA lead reviews each candidate, decides escalate / record-only / dismiss, drafts the MedWatch Form 3500A from our pre-filled template, and the audit log captures every state transition for FDA inspection support.
- The 15-business-day clock, automated. We compute the §605(b)(1) deadline (skipping OPM federal holidays) and email reminders 7 / 3 / 1 business days out. Miss-the-deadline is the failure mode this product eliminates.
- Manual entry too. AEs don't always come through Gorgias — phone, retailer escalation, social DM. The inbox accepts manual entry so every AE you receive lives in one place with one workflow.