Product Compliance

Product Compliance is a module within ArisGlobal's LifeSphere® platform designed to support life sciences companies in managing and exchanging medicinal product data in accordance with xEVMPD and IDMP regulatory requirements. It is intended for organizations that need to standardize product data governance, maintain submission compliance, and manage the full product data lifecycle without requiring technical expertise from end users.

ArisGlobal works with more than 220 global life sciences companies, CROs, and government health authorities, including regulatory bodies such as the FDA, Health Canada, and NMPA. Product Compliance sits within this broader regulatory information management (RIM) context, supporting teams responsible for product data submissions and ongoing data maintenance.

Core Capabilities

• Manages and facilitates the exchange of product data according to xEVMPD and IDMP requirements.
• Standardizes product data governance and lifecycle management across the organization.
• Provides a centralized environment for medicinal product data to support reuse, impact assessment, and data updates, functioning as a single source of truth.
• Ensures adherence to agency requirements and compliance with xEVMPD and IDMP standards without requiring technical knowledge from users.
• Automates the creation and update of medicinal products as part of the overall RIM lifecycle.

Features

• Product Data Management: Supports product data standardization and lifecycle management.
• xEVMPD Support: Includes embedded workflows for xEVMPD submission and ongoing data maintenance.
• IDMP Compliance: Provides built-in IDMP support and validation aligned with regional Implementation Guidelines.
• Interoperability: Offers direct gateway connectivity and integrations with SPOR (Substances, Products, Organisations and Referentials).
• Data Enrichment: Automates data extraction and validation to improve overall data quality.
• Interactive Dashboards: Provides insights into managing product information through visual reporting tools.

Data Quality and Governance

• Increases consistency and quality of product data through a controlled, centralized repository.
• Supports impact assessment when data changes occur across the product lifecycle.
• Reduces manual effort through process automation for product creation and updates.

Product Compliance is part of ArisGlobal's LifeSphere® technology suite. ArisGlobal is headquartered in the United States and maintains regional offices in Europe, India, Japan, and China.