⚠️ EU Hub SLA enforcement is tightening in 2026. DE, CY, and IE require resolution within 2 working days — with automatic escalation to NCAs.
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Sentry · EU Compliance Module

EU Alert Management

Structured alert resolution for pharmaceutical manufacturers and MAHs. Connected to EU-AMS. Integrated with your existing Level 4 and built to close alerts faster, without changing your serialization setup.

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Overview

EU Alert Management Overview

EU Hub SLA enforcement is tightening in 2026. Germany, Cyprus, and Ireland now require alert resolution within 2 working days, with automatic escalation to National Competent Authorities for missed deadlines. More countries are following.

Most manufacturers are still managing alerts the same way: shared inboxes, spreadsheets, and manual follow-up. That approach can't scale with rising alert volumes, stricter SLAs, or audit demands.

Sentry's EU Alert Management module brings structure and automation to every phase of alert resolution — from intake and pre-check through assignment, investigation, and closure. It connects directly to EU-AMS, integrates with your existing Level 4 system via API regardless of vendor, and deploys without disrupting your current serialization infrastructure.

It works for Antares Vision Group customers and manufacturers on other Level 4 platforms alike.

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EU Alert Management module
Capabilities

Product Features & Business Value

Product Features / Capabilities
  • Automated closure of alerts that meet pre-defined resolution criteria — no manual review required
  • L4 pre-check at intake: validates and prioritizes alerts against your existing Level 4 system before assignment, any vendor
  • Connected to EU-AMS; NMVS integration in progress via local systems or preferred communication method (including email)
  • Alert grouping by GTIN, batch, or error code for faster triage
  • Auto-assignment by user role, market, or product type
  • Structured tickets with owners, due dates, resolution fields, and built-in comment threads and escalation workflows
  • Role-based access for secure CMO and internal team collaboration
  • Real-time dashboards by market and product: open, overdue, and resolved
  • Deploys standalone or integrates via API with your compliance stack — no changes to your existing Level 4 systems required
Business Value / Benefits
  • Meet country-specific SLA deadlines across all EU markets, including DE, CY, and IE
  • Reduce manual workload through automated closure of non-investigable alerts
  • Eliminate reliance on spreadsheets, email threads, and informal tracking
  • Gain real-time visibility into alert status, ownership, and resolution timelines across your entire portfolio
  • Enable consistent, audit-ready closure documentation at every stage
  • Support secure collaboration between internal teams and CMOs without shared credentials
  • Scale to handle alert volumes across multiple markets, products, and facilities
  • Protect patient access by preventing delays caused by missed SLA deadlines
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Deployment

Implementation and Support

Fast to Deploy, Minimal IT Lift

The EU Alert Management module deploys quickly with minimal IT effort — no changes to your existing Level 4 systems or serialization infrastructure required.

Configured to Your Workflow

Our team configures the module to match your organization's roles, markets, products, and workflow requirements.

EU-AMS Connected. NMVS In Progress.

The module connects to EU-AMS today. NMVS integration is expanding via local systems or your preferred communication method, including email.

Onboarding, Training, and Ongoing Support

We provide onboarding, training, and ongoing support to ensure your team is resolving alerts faster from day one.

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Get Started

Ready to Take Control of EU Hub Alerts?

SLA deadlines won't wait. Book a personalized walkthrough to see how the EU Alert Management module handles your alert volume — from automated intake through audit-ready closure.

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