For Regulated Industries

Compliance built for the world's most demanding regulators.

FDA, EU MDR, DORA, NIS2 — all in one platform.

Vigil is the only GRC platform purpose-built for regulated industries — with FDA 21 CFR Part 11 Computer System Validation automation, EU MDR Annex 11 workflows, and DORA and NIS2 compliance built in from day one.

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The Challenge

The problems we were specifically built to solve.

FDA 21 CFR Part 11 CSV projects costing $40,000+ in annual consulting fees

IQ/OQ/PQ protocols built as Word documents with no version control or audit trail

DORA ICT register maintained in spreadsheets that fail regulatory inspections

NIS2 obligations mapped manually to controls weeks after effective dates

EU MDR Annex 11 validation documentation scattered across email and SharePoint

No single platform linking regulatory obligations to security controls and evidence

How Vigil Helps

Built for the way you work.

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FDA 21 CFR Part 11 CSV

The only GRC platform with Computer System Validation automation. Generate IQ/OQ/PQ protocols, validation master plans, and summary reports — no consultants required.

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EU MDR Annex 11

Medical Device Regulation Annex 11 compliance workflows. Validation master plan and summary report generation aligned to GAMP 5 guidelines.

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DORA Full Coverage

ICT risk management, incident reporting, TLPT, and third-party contract register — every DORA requirement tracked and reported.

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NIS2 Mapping

NIS2 obligations automatically mapped to your CSF 2.0 controls and ISO 27001 Annex A — with gap analysis and remediation tracking.

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Regulatory Change Intelligence

Clio monitors FDA, EMA, ESMA, and all major regulatory bodies. New guidance is mapped to your obligations before your competitors even read the press release.

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Audit-Ready Evidence

Evidence is collected continuously and organized by regulatory requirement. When an inspector arrives, grant read-only access with one link.

Vigil Products Included

ComplianceGuard

FDA 21 CFR Part 11 CSV and EU MDR Annex 11

Clio

FDA, EMA, ESMA regulatory intelligence

PostureIQ

CSF 2.0 posture scoring and board reporting

Vigil VRM

DORA ICT third-party risk register