Vigilance – find, manage and act
on safety signals
Post-market surveillance combines vigilance searching, adverse event monitoring, and complaints management across your entire organization. Vigilance consolidates safety data from published literature, MAUDE, customer complaints, and field reports into one auditable system. Your teams catch every signal, meet regulatory deadlines, and protect patient safety with confidence.
Connected Safety Monitoring
Post-market surveillance efforts collapse under siloed data, manual tracking, and growing regulatory pressure — making safety oversight reactive instead of proactive
Features that power scalable, proactive safety monitoring
Vigilance unifies post-market surveillance, automates workflows, and helps you act on safety signals before they escalate
Intelligent duplicate removal
The system automatically detects duplicates by DOI, PMID, and titles and offers manual validation if necessary.
Automate PSUR Scheduling
Set report frequencies and deadlines by product class. The system tracks due dates and reminds you automatically.
Centralize Global Surveillance
Manage local and international data in one system. No more spreadsheets or fragmented dashboards.
Generate reports to meet regulatory requirements
Export in formats for MDR, IVDR, FDA with PRISMA, EndNote, Word, Excel.
Intelligent duplicate removal
The system automatically detects duplicates by DOI, PMID, and titles and offers manual validation if necessary.
Scale Without Adding Headcount
Configurable workflows and alerts keep your team focused. Handle growing product lines with ease.
Generate Submissions in Hours
Pre-built PSUR and report templates pull from real-time data. Submit with confidence and speed.
Generate reports to meet regulatory requirements
Export in formats for MDR, IVDR, FDA with PRISMA, EndNote, Word, Excel.
A clear path from fragmented inputs to proactive safety reporting
Vigilance connects all your post-market data, monitors signals in real time, and prepares regulatory submissions in a streamlined, structured flow.
- Connect Data Sources
- Monitor & Capture
- Review & Analyze
- Report & Submit
Evidence Cloud Automation
Pathway integrates with your quality systems and document control platforms.
Updates flow directly into your compliance calendar. Export summaries to your QMS.
Link regulatory requirements to your technical documentation.
100%
on-time PSURs
Reports submitted without delays or escalations.
40 Hours
saved per report
PSURs, complaints, and safety trends delivered instantly.
Trusted for global safety surveillance
Vigilance delivers control and visibility in post-market surveillance. Built to scale with your portfolio while reducing risk and effort.
20+
global data sources
Critical safety data captured before it’s too late.
43%
fewer audit findings
Observed across teams switching from manual workflows.
All modules connected in one platform
Evidence Cloud™
Module Connections
CiteSource
14 days demo access
Other modules
that work with Pathway
Evidence Cloud™ is not a separate tool, but an interconnected system.
The CiteSource module integrates with other parts of the platform to build
a full cycle of regulatory documentation
