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Modules/Risk & Safety/Safety Data Sheets
Risk & Safety

Safety Data Sheets

Manage and distribute safety data sheets for chemicals, materials, and hazardous substances used in your manufacturing and operations. Ensure compliance with GHS requirements and give your teams instant access to critical safety information.

Key Capabilities

What you get with the Safety Data Sheets module.

Centralized SDS repository with version control and expiration tracking
GHS-compliant formatting with hazard classification and pictograms
Quick access for employees to view safety information for any material
Automated alerts when SDS documents need updating or renewal
Supplier SDS management with incoming document tracking and validation

How It Connects

Safety Data Sheetsdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.

Ready to see Safety Data Sheets in action?

Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Safety Data Sheets works within your specific compliance context.

More in Risk & Safety

Explore other modules in the Risk & Safety category.

Risk Management

Implement a complete ISO 14971-compliant risk management process from hazard identification through post-production monitoring. Maintain living risk management files with dynamic risk matrices and full traceability to risk controls and verification activities.

Complaint Handling

Capture, investigate, and resolve product complaints with built-in regulatory reporting workflows. Ensure timely investigation and link every complaint to risk assessments and CAPA actions for continuous improvement and full regulatory compliance.

Benefit-Risk Analysis

Systematically evaluate the clinical benefits of your products against their residual risks to support regulatory submissions and market access decisions. Document your benefit-risk determination in a structured format that meets EU MDR and global regulatory expectations.

Adverse Event Reporting

Report and track adverse events with workflows aligned to global regulatory requirements including EU MDR vigilance and FDA MDR reporting. Ensure timely submissions to authorities and maintain complete records of every reportable event.

Field Safety Notices

Prepare, approve, and distribute field safety notices efficiently when corrective actions in the field are required. Manage the entire FSN lifecycle from drafting through distribution tracking, ensuring affected customers and authorities are notified promptly.

Recall Management

Coordinate product recalls and field safety corrective actions with a structured process that ensures rapid response and complete traceability. Track affected units, manage customer notifications, and document the entire recall from initiation through closure.