Key Features/Benefits

  • Maintains an authoritative, “single source of truth” of product and approved regulatory data
  • Pre-validated Industry Standard Practices (content and process templates) deliver faster deployment and harmonized process implementation
  • Guided data entry aids even infrequent users through workflow tasks, wizards, alerts and more
  • Multi-tenant, cloud- based solution  insulates against changing regulations and maintenance costs
  • Maintains complete and accurate registration history with version control
  • Manages change requests, variations and regulatory interactions
  • Complies with major regulations such as IDMP, xEVMPD and UDI
  • Provides seamless integration with 3rd party systems

Background

For many pharmaceutical companies, maintaining and sharing accurate and up-to-date information on their products is a significant Regulatory Affairs challenge, often resulting in a major disconnect between internal departments such as manufacturing, pharmacovigilance and quality. The disconnect found in outsourced or offshored manufacturing of products can be especially difficult, often resulting in significant compliance issues that can lead to administrative sanctions or worse batch recalls and ultimately withdrawal of the product.

Changing regulations, such as the move toward IDMP electronic submissions, has made it harder for today’s legacy regulatory information management system (RIMS) to support the volume and complexity of regulatory documentation and information required for global compliance.

Cloud-based RIM solutions now provide higher system availability and adaptability to changing global regulations to provide the necessary scalability, integration, automation and the all-important single source of truth.

LifeSphere™ RIMS – Cloud-Based Regulatory Information Management System with IDMP Compliance

LifeSphere RIMS™ (Regulatory Information Management System) is the cloud-based Regulatory Information Management System (RIMS) that is fully IDMP-compliant. Utilizing a process and workflow-driven approach, LifeSphere™ RIMS provides intuitive, mobile-enabled handling of all regulatory affairs processes by headquarters, regulatory operations, regional managers and local affiliates.

Track and Monitor All Registration Data

LifeSphere™ RIMS captures and stores detailed product information and allows authorized users to track and monitor the country-specific and global registration data on a drug and/or medical device product. Compliant with the IDMP, XEVMPD and UDI specifications, LifeSphere™ RIMS allows you to maintain accurate product approval data including approved manufacturing specifications for every region while managing any specific product obligations and commitments necessary to maintain the product license.

Manage all Regulatory Submission Activity and Resources

Eliminating the need for time-consuming manual tracking, the regulatory planning module enables organizations to manage the numerous activities and resources associated with global regulatory submissions automating the definition, distribution and reporting of project plans at the global and local/regional level. As a result, LifeSphere RIMS™ improves visibility across the organization, giving users and management a global view of potential delays and resource conflicts, enabling faster, informed decision making at lower cost while ensuring compliance with various regulations such as xEVMPD, 21 CFR 11, UDI and ISO IDMP.

regulatory information management