Infosys Compliance Edge solution suite for Regulatory Information Management

This video provides an in-depth overview of the Infosys Compliance Edge solution suite, a purpose-built platform designed to address the escalating global regulatory complexity faced by Life Sciences organizations regarding regulatory submissions and information management. The core objective of the solution is to accelerate time-to-market, reduce cycle times with regulators, and maximize research investments by streamlining the entire regulatory submission process, from planning and document creation to review, approval, tracking, and final submission. The presentation frames regulatory submission as a critical function that, if mismanaged, prevents organizations from realizing the benefits of their R&D investments.

The need for a comprehensive solution like Compliance Edge stems from several industry challenges, including the exponential increase in global regulatory complexity, the necessity for timely responses to regulatory queries, the demand for reduction or elimination of regulatory notices, fines, and product recalls, and the persistent issue of product registration inaccuracies in the market. Furthermore, the industry requires a standardized set of regional tools for submission validation and publishing of information. Infosys positions Compliance Edge as a next-generation regulatory platform that facilitates collaborative and efficient work while ensuring strict adherence to regulatory requirements and timely submissions across the enterprise.

Architecturally, the solution is built using Open Text Documentum content server and other leading technology components, serving as an end-to-end compliance platform delivered via a Software as a Service (SaaS) model hosted by Infosys. Its major functional components are robust and integrated, including comprehensive document management, regulatory publishing, systematic submission tracking, and advanced reporting capabilities. Key features highlighted include systematic monitoring and tracking of regulatory queries, a unified user experience with optimized search and intuitive dashboards, seamless workflows, and real-time alerting and notifications. Crucially, the platform addresses the challenge of unsynchronized data across disparate departments by providing a unique and common view of regulatory information. The solution is touted as easily customizable and scalable, offering extended support for multiple applications and vendors within the often-scattered technology landscape of life sciences.

The video concludes by citing tangible business benefits witnessed by a leading life sciences organization that adopted the platform. These benefits include a multifold reduction of product recall or failure and inaccuracies in the product registration trail. Additionally, the organization experienced a twofold increase in the likelihood of schedule adherence for product submissions and achieved 100% compliance with legal and litigation requirements. These metrics underscore the platform's ability to not only manage data but also drive significant operational efficiency and mitigate critical business risks associated with non-compliance.

Key Takeaways: • Strategic Importance of RIM: Regulatory Information Management (RIM) is presented as a critical function that directly impacts the realization of research investments and time-to-market, emphasizing that inefficient submission processes can stifle organizational growth and market access. • Addressing Global Complexity: The primary driver for the solution is the exponentially increasing complexity of global regulations, necessitating a centralized platform capable of managing diverse regional requirements and submission standards. • End-to-End Submission Lifecycle Management: The solution covers the full spectrum of regulatory submissions, encompassing planning, document authoring, review, approval, publishing, and continuous tracking, ensuring a seamless and controlled process. • SaaS Delivery Model: Infosys Compliance Edge is delivered as a Software as a Service (SaaS) solution, hosted by Infosys, which reduces the business cost associated with infrastructure management and allows for easier customization and scalability. • Core Functional Components: The platform relies on four major functional pillars: document management, publishing capabilities, systematic tracking, and robust reporting/business intelligence dashboards for actionable insights. • Data Synchronization and Unified View: A key capability is the ability to handle unsynchronized data across various internal departments, providing a single, unique, and common view of regulatory information, which is essential for accurate submissions. • Risk Mitigation and Compliance Metrics: The solution directly addresses regulatory risk by aiming for the elimination of regulatory notices, fines, and product recalls, citing a leading organization achieving 100% compliance with legal requirements post-implementation. • Accelerated Time-to-Market: By optimizing regulatory submissions and reducing cycle times with regulators, the platform promises to accelerate the introduction of new products to the market, maximizing the value of research investments. • Technology Foundation: The platform is built on established enterprise content management technology, specifically mentioning the use of Open Text Documentum content server, suggesting a robust and scalable foundation for document control. • Quantifiable Business Outcomes: Specific metrics cited include a multifold reduction in product recall/failure and registration inaccuracies, alongside a twofold increase in the likelihood of schedule adherence for product submissions, providing clear ROI indicators. • Systematic Query Monitoring: The solution includes systematic monitoring and tracking capabilities for regulatory queries, ensuring timely and accurate responses to health authorities, a crucial aspect of maintaining good standing with regulators. • Workflow and Alerting: Seamless workflows, real-time alerting, and notification systems are integrated to ensure that critical deadlines are met and that relevant personnel are immediately informed of status changes or required actions.

Tools/Resources Mentioned:

• Infosys Compliance Edge (Solution Suite)
• Open Text Documentum (Content Server Technology)

Key Concepts:

• Regulatory Information Management (RIM): The comprehensive system and processes used by life sciences organizations to manage, track, and submit all regulatory data and documentation required by global health authorities.
• Regulatory Submissions: The formal process of submitting documentation (e.g., NDAs, BLAs, MAAs) to regulatory bodies (like the FDA or EMA) to gain approval for marketing a drug or medical device.
• Schedule Adherence: The ability of an organization to meet predefined timelines and deadlines for regulatory submissions, which is critical for market entry and competitive advantage.