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Modules/Core QMS/Electronic Signatures
Core QMS

Electronic Signatures

Achieve full 21 CFR Part 11 and EU Annex 11 compliance with validated electronic signatures. Provide tamper-evident audit trails, user authentication controls, and meaning-based signatures that satisfy the most rigorous regulatory expectations.

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Part of Core QMS

Document Management HubDocument ControlSOP Template LibraryISO TemplatesCAPA ManagementPreventive ActionsDeviation ManagementNon-Conformance ReportsTraining ManagementTraining SessionsTraining HubRecord ArchivalNotes

Regulatory Context

FDA 21 CFR Part 11 — Electronic records and electronic signatures
EU MDR Article 10 — General obligations of manufacturers
EU Annex 11 — Computerised systems

Key Capabilities

What you get with the Electronic Signatures module.

21 CFR Part 11 compliant electronic signatures with meaning declarations
Tamper-evident, time-stamped audit trails for all signed records
Multi-factor authentication options for high-assurance signing
Configurable signature workflows supporting sequential and parallel approvals
Complete signature history with signer identity, timestamp, and meaning

Why It Matters

How Electronic Signatures helps your organisation.

Go fully paperless with legally binding electronic signatures
Accelerate approval turnaround by eliminating physical sign-off delays
Provide tamper-evident records that satisfy the most rigorous regulatory inspections

How It Connects

Electronic Signaturesdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.

Document Management HubDocument ControlRecord Archival

Ready to see Electronic Signatures in action?

Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Electronic Signatures works within your specific compliance context.

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More in Core QMS

Explore other modules in the Core QMS category.

Document Management Hub

Centralize all quality documents in a single, secure hub with powerful search, categorization, and lifecycle management. Ensure every team member always accesses the latest approved version while maintaining full traceability across your entire document ecosystem.

Document Control

Manage the entire lifecycle of quality documents with version control, electronic signatures, and automated workflows. Ensure every SOP, work instruction, and form meets regulatory requirements with a fully auditable document management system built for regulated industries.

SOP Template Library

Accelerate SOP creation with a curated library of industry-standard templates designed for regulated environments. Reduce drafting time and ensure consistency across your organization with templates aligned to ISO 13485, EU MDR, and FDA requirements.

ISO Templates

Access a comprehensive set of ISO-compliant document templates that cover the full scope of your quality management system. Save weeks of preparation with templates structured to meet ISO 13485, ISO 14971, and other critical standards out of the box.

CAPA Management

Track and manage all corrective and preventive actions with built-in root cause analysis tools. Ensure every CAPA follows a structured workflow from identification through effectiveness verification, with full audit trail and regulatory-ready documentation.

Preventive Actions

Proactively identify and eliminate potential quality problems before they occur. Systematically analyze trends, near-misses, and risk indicators to implement preventive measures that strengthen your quality system and reduce costly corrective actions.