Labeling

Labeling is a module within ArisGlobal's LifeSphere® platform designed to support end-to-end labeling change management and compliance tracking for life sciences organizations. It is intended for companies that need to manage labeling data and documents across their full lifecycle, including local and global operations, while reducing the risk of regulatory non-compliance.

The tool targets life sciences companies, CROs, and regulatory affairs teams that require structured control over labeling processes, from initiating changes through to submission and approval. ArisGlobal works with more than 220 global life sciences companies and government health authorities, including the FDA, Health Canada, and NMPA.

Core Capabilities

• Process Management: Supports both local and global end-to-end labeling processes within a single system.
• Change Management: Tracks the review, tracking, and implementation of labeling changes to maintain control and auditability.
• Workflow Automation: Enables automated notifications and process triggers to reduce manual intervention and rework.
• Cross-Functionality: Supports workflows that span multiple processes and departments within an organization.
• Downstream Integration: Connects to submission and approval processes as part of the broader end-to-end Regulatory Information Management (RIM) workflow.
• Dashboarding: Provides interactive dashboards that give visibility into labeling changes and outstanding actions.

Key Outcomes Described

• Efficiency: Streamlined and automated labeling management workflows are intended to increase productivity and reduce rework.
• Compliance: Enhanced control over labeling changes and their implementation is designed to minimize regulatory non-compliance risk.
• Lifecycle Management: Supports the management, reuse, and control of labeling data and documents throughout their lifecycle.
• Visibility: Compliance tracking and dashboards provide added insight into labeling status and required actions.

Labeling is part of the LifeSphere® platform, which also includes regulatory, pharmacovigilance, and medical affairs capabilities. ArisGlobal is headquartered in the United States with regional offices in Europe, India, Japan, and China. The platform also incorporates automation features through NavaX, ArisGlobal's latest automation offering within LifeSphere.