How does QT9 QMS streamline GMP compliance?

QT9 QMS provides a comprehensive suite of tools to document, monitor, and manage GMP processes, ensuring full traceability and consistent quality control.

How does QT9 QMS simplify adverse event reporting?

QT9 QMS automates the collection, analysis, and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs), ensuring timely submission to the FDA.

How does QT9 QMS simplify registrations?

QT9 QMS centralizes facility and product registration data, automates reminders and alerts, and supports customizable templates to streamline the registration process.

How does QT9 QMS facilitate comprehensive safety substantiation?

QT9 QMS includes applications to gather, evaluate, and store product safety data, with document control and audit trails to support compliance and product safety.

How does QT9 QMS support recall management?

Built-in traceability in QT9 QMS enables fast identification and removal of affected products, ensuring effective and timely recall management.

MoCRA is the Modernization of Cosmetics Regulation Act, new mandatory cosmetics safety regulations in the U.S. effective 2025 that aim to further protect consumer safety.

What are the new MoCRA requirements?

Under MoCRA, cosmetics manufacturers must adhere to mandatory GMP, report Adverse Events and Serious AEs to the FDA, substantiate product safety, register facilities (renewed biennially), and comply with FDA-mandated recalls.

MoCRA | Modernization of Cosmetics Regulation QMS Software

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.

Streamline GMP compliance

Get a comprehensive suite of tools that work together to document, monitor and manage GMP processes.

Adverse Event reporting

Automate the collection, analysis and reporting of Adverse Events and ensure timely submission to the FDA.

Simplified registrations

Simplify facility and product registrations with centralized data, automated reminders and alerts and customizable templates.

Comprehensive safety substantiation

Get applications that facilitate the gathering, evaluation and storage of product safety data, including document control and audit trails.

Recall management

Built-in traceability enables faster response to potential recalls, ensuring affected products are identified and removed from the market.

Pre-validated QMS software

QT9 QMS is pre-validated for accelerated compliance.

FDA and ISO compliance out-of-the-box
Rapid cloud deployment for faster implementation
Audit-ready with timeline traceability
Electronic signature approvals and secure access controls
Continuous validation and updates

• ISO 13485
• ISO 9001
• ISO 14001
• ISO 17025
• AS9100
• MoCRA

• FDA 21 CFR Part 11
• FDA 21 CFR Part 210/211
• FDA 21 CFR Part 820
• EU GMP
• EU MDR
• GxP Compliance

QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.
Reduces downtime waiting for your QMS to be approved for use.
Minimizes the risk of any failed audits due to flawed validation protocols.

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.

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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.

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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.

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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.

Explore Modules

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.

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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.

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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.

Stricter Good Manufacturing Practice (GMP) compliance: Where once GMP compliance was voluntary, MoCRA will now require cosmetics manufacturers to adhere to GMP practices.
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.
Safety Substantiation: Cosmetic companies must now keep records that adequately substantiate safety, as evaluated by qualified experts.
Facility Registration: Manufacturers and processors must register their facilities with the FDA and renew registration every two years.
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.

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Modernization of Cosmetics Regulation Act (MoCRA) Compliance Made Easy