Modernization of Cosmetics Regulation Act (MoCRA) Compliance Made Easy
Centralize and automate compliance information for the Modernization of Cosmetics Regulation Act (MoCRA) with QT9™ QMS. Get timeline traceability that makes it simple to quickly track changes and a cloud-based platform that can easily adapt to future regulatory updates.
Simplified Quality Management
QT9 QMS automates workflows with controlled processes.
Hassle-Free Compliance
QT9 QMS collects and prioritizes all MoCRA mandates.
Connect & Collaborate Online
QT9 QMS cross-links and centralizes data and workflows.
Continuous Improvement
QT9 QMS enables you to consistently improve quality.
MoCRA preparedness for modern cosmetics companies
Manage MoCRA compliance and synchronize documentation with anyone, anywhere.
Explore how MoCRA compliance software can benefit your organization
Streamline GMP compliance
Adverse Event reporting
Simplified registrations
Simplify facility and product registrations with centralized data, automated reminders and alerts and customizable templates.
Comprehensive safety substantiation
Recall management
See how QT9 QMS stacks up against MoCRA regulations
QT9's comprehensive quality management system is your all-in-one MoCRA solution.
Adverse Events Reporting
QT9 QMS Document Control Module | Customer Feedback Module | Electronic Batch Records Integration
GMP Compliance
25+ Modules Geared to GMP, FDA, ISO, ICH and EU MDR Compliance
Facility Registration
QT9 QMS Document Control Module | Supplier Management Modules | Automated Reminders
Safety Substantiation
QT9 QMS Document Control Module | Cloud-Based Collaboration
Records Management
QT9 QMS Audit Management Module | Document Control Module
Recall Management
QT9 QMS Provides Built-In Traceability | Electronic Batch Records Integration
Pre-validated QMS software
QT9 QMS is pre-validated for accelerated compliance.
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FDA and ISO compliance out-of-the-box
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Rapid cloud deployment for faster implementation
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Audit-ready with timeline traceability
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Electronic signature approvals and secure access controls
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Continuous validation and updates
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• ISO 13585 |
• FDA 21 CFR Part 11 |
QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).
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Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.
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Reduces downtime waiting for your QMS to be approved for use.
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Minimizes the risk of any failed audits due to flawed validation protocols.
Unlimited Support Included
Have a question? QT9 support is here to help for all QT9 QMS users.
FAQ: MoCRA compliance
MoCRA is an acronym for the Modernization of Cosmetics Regulation Act, which are new mandatory regulatory compliance rules that take effect in the United States beginning in 2025. The goal of the new rules is to ensure the safety of cosmetic products for consumers.
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Stricter Good Manufacturing Practice (GMP) compliance: Where once GMP compliance was voluntary, MoCRA will now require cosmetics manufacturers to adhere to GMP practices.
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Reporting of Adverse Events: Cosmetic companies will now be required to report AEs and Serious Adverse Events (SAEs) to the FDA. Previously reporting was voluntary.
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Safety Substantiation: Cosmetic companies must now keep records that adequately substantiate safety, as evaluated by qualified experts.
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Facility Registration: Manufacturers and processors must register their facilities with the FDA and renew registration every two years.
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Recall Authority: MoCRA also establishes FDA authority to order a mandatory recall if they deem a product to be harmful to consumers.
For more detailed information visit: MoCRA Guidance
QT9 QMS can help simplify your path toward MoCRA compliance. We offer more than 25 modules that come standard, including Document Control, Audit Management, Customer Feedback, Supplier Management and Risk Management.
QT9 QMS is a highly rated quality management solution geared toward regulatory compliance and efficient systems. Our QMS offers an easy user interface and is backed by free software updates, full customer support, an available ERP integration and Business Intelligence tool.
Explore more QT9 quality and compliance resources
QMS Software Validation: Ensuring FDA, ISO and Industry Compliance
From Concept to Market: FDA Approval Process for Medical Devices
Data Integrity: A Critical Component of FDA and ISO 13485 Compliance
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