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Beacons

Regulatory change,
monitored 24/7.

Deploy a Beacon on any regulatory source: FDA guidance, EU MDR deadlines, ISO updates, PMDA changes. Qualio scans continuously and flags only the changes relevant to your obligations, your products, and your frameworks.

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A Beacon flagging new FDA guidance for review, moving through relevance filter, impact assessment, Compliance Agent and approval, with its audit trail

700+ life sciences companies

VerantosTrivium VetAvectasiMixBiofidelity
4.7/5 on (667 reviews)

Continuous regulatory monitoring.

Track FDA, ISO, EU, PMDA, NMPA, ANVISA, and custom sources without manual checking.

Beacons monitoring six regulatory sources: FDA guidance, EU MDR, ISO standards, PMDA, NMPA and ANVISA

Relevance, not noise.

Filter updates against your obligations, products, and active frameworks.

This week’s regulatory updates filtered against your obligations, products and frameworks, with 148 updates scanned

Updates where teams work.

Deliver relevant changes through Slack, Teams, or email.

Delivery to Slack and Microsoft Teams, with a Qualio Beacons alert about a revised FDA guidance affecting 3 controls

From change to impact.

Dispatch the Compliance Agent to assess affected controls and draft remediation, with approval and an audit trail.

Impact assessment of an FDA guidance update drafted by the Compliance Agent, listing the affected controls

Platform connections

Regulatory changes

Regulatory changes can dispatch the Compliance Agent to assess impact and draft remediation.

Alerts

Alerts reach teams through Slack, Teams, or email, with findings captured in the audit trail.