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 changes.

 

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MoCRA preparedness for modern cosmetics companies.

Manage MoCRA compliance and synchronize documentation with anyone, anywhere.

Simplify quality management 

QT9 QMS automates quality workflows with controlled processes.

Get hassle-free compliance

QT9 QMS collects & prioritizes all MoCRA mandates.

Connect & collaborate online

QT9 QMS cross-links & centralizes data and workflows.

Continual improvement

QT9 QMS helps you consistently improve quality.

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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

Section 605

GMP Compliance

25+ Modules Geared to GMP, FDA, ISO, ICH and EU MDR Compliance

Section 606

Facility Registration

QT9 QMS Document Control Module | Supplier Management Modules | Automated Reminders

Section 607

Safety Substantiation

QT9 QMS Document Control Module | Cloud-Based Collaboration

Section 608

Records Management

QT9 QMS Audit Management Module |
Document Control Module

Section 610

Recall Management

QT9 QMS Provides Built-In Traceability | Electronic Batch Records Integration

Section 611
Explore 25+ Modules Included

Frequently Asked Questions: MoCRA

What is MoCRA?

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.

What are the new MoCRA requirements?
  • 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

How can QT9 QMS help meet MoCRA requirements?

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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Track all your MoCRA compliance records in one place.

QT9's easy-to-use MoCRA quality management system makes traceability and transparency simple for any cosmetics company.

Built-In Dashboard

Quickly view MoCRA records from the QT9 dashboard, and easily personalize the view.

Traceability & Transparency

QT9™ QMS includes web portals for customers, suppliers and employee training.

Mobile-Friendly

Manage MoCRA records from your desktop, tablet or mobile device from anywhere you have internet.

QT9™ QMS is your flexible MoCRA Quality Management System

QT9 lets you choose modules based on what's best for your organization.

Modules for any business size

With multiple modules to choose from, there's solutions for nearly anyone.

A solution that scales with you

Whether you are a large corporation or a small start-up you can use as many modules as you want.

Cross-Platform Support

Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.

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