V5 for MoCRA Compliance – Cosmetic Safety Enforced Digitally

V5 from SG Systems Global helps cosmetic manufacturers meet the FDA’s Modernization of Cosmetics Regulation Act (MoCRA) by enforcing digital controls over safety substantiation, ingredient traceability, facility registration, and adverse event reporting. Tested. Tracked. Compliant.

Whether you’re formulating skincare, color cosmetics, fragrances, or OTC personal care products, V5 brings structure and enforcement to the critical data points required by MoCRA. No spreadsheets. No manual gaps. Just audit-ready digital compliance built for FDA scrutiny.

“V5 digitized everything from batch records to adverse event tracking. We’re no longer chasing compliance—we’re ahead of it.”
— Head of Regulatory, Cosmetics Manufacturer

Digital Safety Substantiation

MoCRA requires manufacturers to maintain and produce substantiation of cosmetic product safety. V5 enforces this through:

• Centralized storage of toxicological and formulation data per product
• Linking of lab results and testing outcomes to finished product records
• Change control with approval workflow for formulation updates
• Vendor qualification records linked to raw material data
• Digital sign-off for responsible persons under the 4-eyes principle

With every formula version, material spec, and lab result traceable in V5, proving product safety is no longer a manual burden.

MoCRA-Ready Facility & Product Registration

V5 helps maintain up-to-date records to support MoCRA’s product listing and facility registration mandates:

• Facility profiles tied to every batch, including GMP status and inspection history
• Product metadata stored per SKU for FDA listing requirements
• Automated alerts for annual registration reviews and expiries
• Integration-ready data structure for submission to FDA portals

Everything required for registration, recall traceability, or site audit is already logged in real-time in V5—structured, secured, and backed up.

Adverse Event Tracking & Recall Readiness

MoCRA mandates adverse event reporting and record retention for a minimum of six years. V5 enforces this through:

• Adverse event logging tied to batch number, operator, and formulation version
• Escalation workflows into CAPA with internal review and external reporting options
• Full traceability from consumer report to raw material lots used
• Mock recall support with instant trace back and forward for any product

From incident to resolution, V5 captures every data point required to comply with MoCRA’s safety reporting obligations.

“MoCRA’s reporting rules had us worried—until we saw how V5 handled traceability. Everything we need is a few clicks away.”
— Compliance Manager, Skincare Brand

Built-In Enforcement for Cosmetic GMP

MoCRA emphasizes Good Manufacturing Practice (GMP) for cosmetic products. V5 helps enforce GMP by digitizing:

• Line clearance and sanitation with checklist enforcement
• Batch step confirmation tied to operator login and timestamp
• Equipment calibration logs tied to production jobs
• Environmental condition monitoring and alerting
• Label reconciliation and mass balance enforcement

Every manufacturing event, deviation, and quality action is captured and time-stamped in V5—no gaps, no omissions.

The V5 Compliance Ecosystem for Cosmetics

MoCRA compliance is more than just checkboxes—it requires a system. V5 provides that system across:

• Manufacturing Execution System (MES) – Digital batch records, formulation control, and operator accountability
• Warehouse Management System (WMS) – Ingredient traceability, expiry management, and inventory control
• Quality Management System (QMS) – CAPA, audits, SOP tracking, and adverse event workflow
• V5 Connect API – Integrate with LIMS, ERP, and third-party reporting platforms

MoCRA is changing how the cosmetic industry thinks about compliance. V5 makes sure you’re not just keeping up—you’re leading the way.