For Regulated Industries
Compliance built for the world's most demanding regulators.
DORA, NIS2, EU MDR, SOX ITGC — all in one platform.
One Vigil tracks regulated-industry obligations — DORA, NIS2, EU MDR, SOX ITGC — in a single platform, with every requirement mapped to controls and evidence. Computer System Validation support for FDA 21 CFR Part 11 is on the One Vigil roadmap.
The Challenge
The problems we were specifically built to solve.
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Validation documentation maintained 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 documentation scattered across email and SharePoint✕
No single platform linking regulatory obligations to security controls and evidence✕
Audit evidence assembled by hand, under deadline, every single cycleHow Vigil Helps
Built for the way you work.
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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 are reviewed, approved, and then mapped to your CSF 2.0 controls and ISO 27001 Annex A — with gap analysis and remediation tracking.
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EU MDR Tracking
Medical Device Regulation obligations tracked alongside your other frameworks, with evidence organized by requirement and ready for inspection.
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Regulatory Change Intelligence
The Regulatory module maintains a governed catalog of requirement packs. New guidance is drafted, reviewed, and approved before it is published and mapped to your obligations.
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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.
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21 CFR Part 11 — On the Roadmap
Computer System Validation support for FDA 21 CFR Part 11 is on the One Vigil roadmap. Today, the Compliance module tracks Part 11 framework requirements alongside your other obligations — talk to us about timeline.
“One Vigil gave our quality and compliance teams a single, inspection-ready view of evidence across every framework we run.”
Head of Quality & Compliance
Medical Device Manufacturer, $400M Revenue
Ready to see it in action?
Book a 30-minute demo. We'll show you exactly how Vigil works for for regulated industries.