Adverse Event Automation.
MoCRA mandates strict reporting timelines for serious adverse events. Our platform automates intake, triage, and FDA submission to ensure you never miss the 15-day deadline.
Serious vs. Non-Serious.
Not every complaint is a reportable event. MoCRA defines “Serious Adverse Events” specifically (e.g., hospitalization, disfigurement). Our AI triage engine instantly categorizes incoming reports.
One-Click Intake.
Put a QR code on your packaging. Consumers can report issues directly into your compliant dashboard, satisfying the MoCRA requirement for electronic contact information.
Get Intake QR CodeDirect FDA Submission.
When a serious event is confirmed, we auto-populate FDA MedWatch Form 3500A. You review, approve, and we submit electronically to the FDA Safety Reporting Portal (SRP).
The Compliance Vault.
MoCRA requires you to maintain records of ALL adverse events (serious and non-serious) for 6 years (3 years for small businesses). Our vault is audit-ready 24/7.
Signal Detection.
Is that rash an isolated incident or a bad batch? Our analytics engine detects spikes in adverse events, allowing you to recall a lot before the FDA steps in.
Enable Signal MonitoringSignal Detection
Command Center.
Give your “Responsible Person” a dedicated dashboard to oversee safety, approve submissions, and monitor deadlines across your entire product portfolio.
Critical Path.
The clock starts the moment you (or anyone in your company) becomes aware of a serious adverse event. Our timeline tracker ensures you hit every milestone before the FDA deadline.
Retailer Integration.
Complaints on Amazon or Sephora reviews can count as “awareness” of an event. We help you integrate feedback loops to capture these external signals instantly.
What is Serious?
MoCRA expands the definition of “serious” to include significant disfigurement (like serious rashes) and infections. Know exactly what triggers a mandatory report.
Auto Redaction.
When submitting to the FDA, patient privacy is paramount. Our system automatically strips PII (Personally Identifiable Information) from the MedWatch form before submission.
Global Monitoring.
For brands sold internationally, an adverse event in Europe can trigger a reporting requirement in the US. We aggregate safety data across all your markets.
Mandatory SOPs.
The FDA requires you to have written procedures for adverse event management. Our platform enforces these steps digitally, creating an unshakeable defense.
One-Click Export.
When the FDA inspector arrives, they will ask for your adverse event log. Generate a compliant, formatted PDF report instantly. No scrambling.
Export for Inspection
Generate a full adverse event history log compliant with FDA audit requests.
Signal to Recall.
If we detect a cluster of serious events associated with a specific batch, the system alerts you immediately so you can initiate a voluntary recall before the FDA mandates one.
Staff Training.
Your customer service team is your first line of defense. We provide MoCRA-specific training modules to ensure they know how to recognize and escalate a serious report.
Full MoCRA Safety Suite
Everything you need to manage adverse events legally.
MedWatch Generation
Auto-fill FDA Form 3500A with zero errors.
Audit Trail
Immutable logs of every report and action taken.
SOPs Included
Standard Operating Procedures for safety handling.
Platform vs. Spreadsheets.
Manual tracking is a liability. Automate safety to reduce risk.
Don't risk a 15-day deadline.
Automate your adverse event management and sleep soundly.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
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