FDA QMSR Is Live. Your Documentation Infrastructure Should Be Ready.
The FDA’s new QMSR regulation (effective February 2, 2026) harmonizes with ISO 13485 and raises the bar on documentation, version control, training records, and CAPA. Amarel builds compliance into your knowledge infrastructure — so audits become evidence retrieval, not reconstruction.
Industry Pain Points
QMSR Compliance
New FDA requirements demand robust version-controlled documentation, training records, and CAPA documentation. Manual systems create audit risk.
Device History Records
Paper DHRs are incomplete, illegible, and audit-vulnerable. GMP compliance demands contemporaneous digital records.
IFU/Service Manual Burden
Every product revision triggers documentation updates across Instructions for Use, service manuals, and training materials.
Field Service Accuracy
Service engineers need current procedures at the point of care. Outdated information creates patient safety risk.
How Amarel Helps
Smart Catalog System (FDA-Ready)
Interactive parts catalogs with full version control, audit trails, and role-based access designed for FDA-regulated environments. Every catalog update is tracked, every user action is logged, and every published version is retrievable for audit evidence.
Manufacturing Process Management (FDA 21 CFR Part 11)
Digitize device history records, production procedures, and quality documentation with electronic signatures compliant with FDA 21 CFR Part 11. Contemporaneous digital records replace paper DHRs, ensuring completeness and legibility for every production run.
Learning Management System (Regulatory Compliance)
Track training completions, certifications, and competency assessments with full audit trails. QMSR requires documented evidence that personnel are trained on current procedures — the LMS provides that evidence automatically, linked to specific document versions.
Content Services
Amarel creates and manages your regulated technical content — Instructions for Use, service manuals, training materials, and labeling content. Every document is version-controlled, linked to product configurations, and updated systematically when design changes occur.
Regulatory Context: FDA QMSR
The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, harmonizes with ISO 13485:2016 and replaces the legacy cGMP requirements. QMSR raises requirements for document control, version management, training records, and corrective/preventive action (CAPA) documentation. Manufacturers who rely on manual, paper-based systems face significant audit risk under the new framework. Amarel’s platform is designed to meet these requirements with built-in version control, electronic signatures, audit trails, and training record management.
Is Your Documentation Infrastructure QMSR-Ready?
30 minutes. We’ll assess your current documentation systems against QMSR requirements and show you the path to audit-ready compliance.
