Complete Guide

Regulatory Information Management System

Regulatory information management, publishing, and document management. Delivered in one simple, unified platform.

Introduction

Regulatory Affairs Platform

Life sciences organizations are focused on improving people’s lives through the development of drugs, medical devices, and other biomedical technologies. Along with this mission comes a sacred trust from the public that these products will be safe and effective not only when they are initially released to the public, but during their lifetime in the marketplace.

Fortunately, regulatory agencies are in place around the globe to ensure this sacred trust is met. It’s the responsibility of Life Sciences organizations to stay current and comply with the rules, guidelines, and requirements of these agencies during the entire drug development process. Life Sciences organizations must:

  • Manage complex regulatory requirements that can evolve over time within their market. This includes new regulatory requirements that are specific to the pharmaceutical, medical device, biologic, food supplement, veterinary and cosmetic industries.
  • Manage a multitude of documents and data that are often found in multiple locations due to disparate, unconnected systems.
  • Work with limited global visibility into upcoming submissions and authorizations being planned by affiliates at the local level. This is often due to the lack of a global RIM solution with a role-based, simplified user interface for infrequent users such as affiliates.
  • Handle integration and scalability challenges while dealing with multiple technology vendors and IT upgrade projects necessary to support a company’s growth and handle changing regulations.
  • Deal with productivity and resource planning challenges, including a heavy volume of submissions of increasingly complex information packets to regulators.

What types of technology solutions are available to solve these challenges?

As with most business challenges, context is key when considering an appropriate strategy. Smaller organizations who are focused on future growth, for example, are likely to prioritize a piecemeal approach to regulatory affairs technology that is designed for scalability. They may, for example, start with a document management system that provides one central location for managing documents and data. With that established, they may also adopt a publishing system to simplify the submissions process. Finally, when ready, they may look toward an end-to-end regulatory information management system to manage the entire regulatory lifecycle in a single application.

Larger organizations are likely to seek out an end-to-end enterprise regulatory technology platform that aligns global teams, automates business processes for efficiency, and delivers complete compliance. In fact, according to Gens and Associates, a regulatory affairs consultancy, 74% of larger organizations plan to move to an end-to-end regulatory information management solution by 2022.

For these organizations, adopting an end-to-end platform has specific benefits, including:

  • Reduced complexity of integrating multiple systems and point solutions
  • Streamlined flow of documents and data across R&D teams, improving collaboration
  • Cost advantages over maintaining on-premise systems, multiple cloud vendors, and middleware needed for integrations between point solutions

Document Management System

LifeSphere Medical Information

Document and content management systems can give life sciences organizations a central location for managing documents and datadelivering efficiency, compliance, and enhanced collaboration across drug development workflows. These systems are required to enable efficient information management within organizationscovering areas like document workflows, control, review, and version control.   

LifeSphere EasyDocs, ArisGlobal’s cloud document and content management system, bringsefficiency to R&D workflowsprovides seamless collaboration, and harmonizes data with assured compliance as the first step for emerging and small organizations seeking an entry point into a unified regulatory platform. While large organizations have the resources and budgets to seek an end-to-end regulatory platform out of the gate, emerging and midsize companies often want a seamless path with step by step adoption opportunities as their needs and budget grow. A cloud document management solution like LifeSphere EasyDocs can be thestarting point for smaller organizations seeking to build a modern regulatory technology ecosystem 

Publishing Tools

LifeSphere Medical Information

Publishing tools help organizations submit information to regulatory authorities about their drugs and devices through streamlined submissions and coordinated regulatory documentation processes. 

LifeSphere Publishing is a simple yet powerful submissions management application that enables life science organizations to easily compile, publish, and validate regulatory submissions with full support for all major global eCTD requirements. LifeSphere Publishing provides an all-in-one, pre-validated cloud application for dossier planning and assembly, and publishing of regulatory submissions, giving regulatory teams the power to accomplish more in a single application. LifeSphere Publishing also uses native workflow automation to proactively navigate users through assigned activities, while hyperlinking and bookmarking capabilities deliver even greater time savings to users.  

End-to-End Regulatory Information Management (RIM) Systems

LifeSphere Medical Information

Regulatory Information Management (RIM) systems were created to assist in maintaining compliance across the entire regulatory lifecycle. Within the RIM category, unified platforms are those that support the end-to-end regulatory process, while seamlessly connecting with key R&D applications across the clinical, Safety, and Quality domains, in particular. Unified platforms can empower life sciences companies who want to manage all the steps in their regulatory submissions process within one application. These systems, and their rich functional depth, help to meet present and future regulatory requirements and provide future-proof compliancewith seamless upgrades delivered over the cloud. They utilize built-in automation and simplify workflows to make regulatory operations faster and more efficient. 

The LifeSphere Regulatory platform delivers end-to-end regulatory information management in an all-new, unified cloud application that accelerates speed to market, enhances data quality, and streamlines collaboration across teams. With LifeSphere Regulatory, regulatory affairs departments can seamlessly plan, track, and gain real-time visibility into all phases of the regulatory submissions process, with seamless connectivity to up and downstream applications.

LEARN MORE ABOUT

LifeSphere Regulatory: Speed. Quality. Collaboration. Delivered in one simple, unified platform.  

Move fast

Save time and effort by managing the end-to-end regulatory process in a single cloud platform with unified data and documents. Native automation streamlines tasks and lets your team focus on what matters most.

Reduce risk

A scalable cloud architecture delivers continuous innovation and stays up to date with the latest regulatory compliance standards, future-proofing an organization’s regulatory environment and reducing risk.

Streamline collaboration

LifeSphere Regulatory is a unified drug development application to streamline cross-functional collaboration and provide a single source of truth across the entire organization. 

 

FACT SHEET
Speed. Quality. Collaboration.
Delivered in one simple unified platform

LifeSphere Regulatory delivers end-to-end regulatory information management in an all-new, fully unified cloud platform that accelerates speed to market, enhances data quality and streamlines collaboration across teams.

WEBINAR
Regulatory Affairs Transformation Drivers for Small and Medium Life Sciences Companies

Regulatory Affairs has become a transformational driver for small and medium-size life sciences organizations. These companies are under considerable pressure to deal with regulatory issues in more automated ways that bring increased agility and control into the process.

WHITEPAPER
Regulatory 2025
Developing an effective 10-year strategy for technology-enabled regulatory transformation

Regulatory departments at most life sciences companies are investing in regulatory information management capabilities as they gear up for a “2020 vision” and assess what regulatory investments are needed to successfully navigate the regulatory framework in the coming decade.

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