Regulatory Information Management (RIM) is the process of managing and tracking all regulatory information that affects a company’s ability to bring products to market safely, on time and within budget. Traditionally, this information has been stored in a variety of systems and in multiple formats including file shares, cloud systems, Excel documents and pen-and-paper repositories.
Using a regulatory information management system can help an organization save time, reduce risk and decrease costs associated with maintaining compliance. Moreover, RIM systems offer a secure, controlled storage environment and prevent the loss of proprietary or sensitive data. Today, the product registration and marketing process is complex, with many steps and requirements for different types of products. Companies often need a centralized system to manage and track the submission life cycle. Regulatory Information Management is an important tool for pharmaceutical, biologics and cosmetics companies to streamline the registration process and avoid duplication of efforts. A Regulatory Information Management System (RIMS) is a software platform that simplifies and organizes the process of product application and registration by enabling end-to-end tracking of activities throughout a product's life cycle. It improves business planning and enables companies to manage the submission processes by capturing, preserving, managing and publishing all the information that is needed for a drug or biologic product to be approved in a given region or country. It also allows companies to team up and enhance the processes for preparing submissions by bringing all information together in a unified environment. RIM is the anchor point for all product information and dossiers submitted to regulatory agencies around the world. Using a Regulatory Information Management system will allow RA teams to improve their productivity by automating workflows and providing real-time access to all required product and agency information. RA professionals often spend up to 50% of their time searching for data, and completing simple requests such as determining whether a particular product can be marketed in a certain country can take days to complete. Having the necessary information available to them in one place and allowing them to quickly search and find it helps RA teams deliver quality products to customers more quickly, saving time and money. A Regulatory Information Management System is the key to delivering effective and efficient product review, approval and release. RIMS solutions enable pharmaceutical companies to stay ahead of their competition and get new products to market much faster. Life Science companies are under constant pressure to comply with the latest regulations. The process is increasingly complicated and difficult to keep up with, which can lead to a number of issues. For example, many regulatory professionals repurpose and rewrite thousands of documents for compliance purposes every quarter. Keeping track of all these documents is an enormous task that can be overwhelming for a RA professional. Fortunately, modern Regulatory Information Management Systems break down the existing data silos and embraces synergies in process alignment and standardization by introducing a converged and connected solution that unites all of a RP’s IT supported RA tasks in a single, integrated, scalable and cost-efficient system. Powered by an open source technology stack that combines the power of eCTD, labeling and EDMS, as well as connections to clinical, PV and other business functions, this modern system can transform the way one plans, execute and manage their regulatory compliance.
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