Integrate compliance with business process over the entire product management lifecycle
- Delivers faster deployment and harmonized process implementation
- Insulates against changing regulations and maintenance costs
- Maintains complete and accurate registration history with version control
- Provides seamless integration with third-party systems through open architecture
Cloud-Based Regulatory Information Management System with IDMP Compliance
LifeSphere RIMS is a cloud-based regulatory information management solution (RIMS) that provides intuitive, mobile-enabled handling of all regulatory affairs processes by headquarters, regulatory operations, regional managers and local affiliates.
LifeSphere RIMS offers adaptability to changing global regulations to provide the necessary scalability, integration, automation and single source of truth. Based on industry standard practices, the regulatory information solution captures and stores detailed product information and allows authorized users to track and monitor country-specific and global registration data. Compliant with the LifeSphere® IDMP, XEVMPD and UDI specifications, the regulatory RIM software solution lets users maintain accurate product approval data while managing any obligations necessary to maintain the product license.
The regulatory planning module streamlines the management of activities and resources associated with global regulatory submissions by automating the definition, distribution and reporting of project plans globally and locally. As a result, LifeSphere RIMS improves visibility across the organization, providing a global view of issues while enabling faster, informed decision-making at a lower cost.