Quality Compliance MoCRA
Modernization of Cosmetics Regulation Act (MoCRA) Compliance Made Easy
Centralize and automate MoCRA compliance information with QT9™ QMS, supported by QT9 ERP for connected operational data. Gain timeline traceability to easily track regulatory changes, along with a flexible, cloud-based platform that can adapt to future updates.
Simplified Quality Management
QT9 QMS automates controlled quality workflows, while QT9 ERP supports connected operational processes.
MoCRA Compliance Readiness
QT9 QMS centralizes and prioritizes MoCRA compliance requirements, supported by QT9 ERP data for visibility across operations.
Connected Data & Collaboration
QT9 QMS cross-links compliance records and workflows, with QT9 ERP providing aligned operational data to support collaboration.
Continuous Improvement
QT9 QMS drives ongoing quality improvement, while QT9 ERP supplies performance data to measure effectiveness and support change.
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 and QT9 ERP Stack up Against MoCRA Regulations
QT9 is Available in the Cloud or On-Premise
Flexible deployment to match your IT strategy without compromising security or speed.
Work smarter with intelligent automation in quality and compliance
QT9 Software’s built-in automation streamlines compliance workflows, quality checks, and alerts, reducing human errors, accelerating decision-making and freeing your team to focus on higher-value work.
Speed up implementation with pre-validated software
QT9 Software offers a fully pre-validated environment, with every module and feature tested and documented for compliance. Save time, avoid costly internal validation processes and go live faster with confidence.
Ensure audit-ready traceability across all processes
Track every action, change and event in real time with QT9 Software. Timeline-based traceability supports inspections, audits and product recalls by providing complete visibility into your processes and product history.
Empower teams with secure, self-service portals
QT9 Software provides dedicated web portals for employees, suppliers and customers, enabling secure self-service access to documentation and data while streamlining collaboration across your organization.
Catch and resolve issues instantly with real-time monitoring
Monitor operations live with real-time dashboards and automated alerts using QT9 Software. Enable proactive responses to nonconformances, minimize downtime and improve compliance outcomes across your organization.
Onboard faster with an intuitive, user-friendly platform
Whether you’re a startup or an enterprise, QT9 Software’s clean, intuitive interface minimizes the learning curve, empowering users to work confidently, complete tasks accurately and stay audit-ready from day one.
Skip the Validation Project. It's Already Done.
Pass FDA and ISO audits faster. IQ/OQ/PQ documentation is already built in.
• Support compliance initiatives with proven software platforms
• Accelerate implementation with cloud-based deployment options
• Maintain audit-ready records with complete traceability
• Utilize electronic approvals and role-based access controls
• Benefit from ongoing software updates and system improvements
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• ISO 13485 |
• FDA 21 CFR Part 11 |
QT9 QMS and QT9 ERP validation supports Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for organizations operating in regulated environments.
Validated software can reduce the time and resources required to establish compliant processes, maintain audit-ready records and support regulatory requirements. By centralizing quality and operational data, organizations can improve efficiency while reducing manual administrative effort.
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
Regulatory Compliance Software: The Manufacturer's Guide to Audit-Ready Quality
Always Audit Ready: The New Standard for FDA-Regulated Manufacturers
Guide to FDA 21 CFR Part 11: Electronic Records, e-Signatures and Audit-Ready Compliance
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