Regulatory Information Management; Help Maintain Compliance throughout the Entire Regulatory Lifecycle

Regulatory information management, as the name implies, is a system/software used to manage regulatory information. In the past, this information has been stored in a multitude of systems, including Excel documents, cloud systems, file shares, and pen/paper repositories. Regulatory information management software ensures that organizations comply with regulations, which helps them to reduce downtime and/or production of the products that are not in line with the set regulatory standards. The software also allows organizations to ensure strict adherence to complex regulations laid down by regulatory authorities.

Regulatory information management has become a major focus among various industries, such as pharmaceutical, biotechnology, and clinical research organizations, among others. Industry analysts agree that companies/organizations are looking at regulatory information management more strategically and seeking to optimize their operational capabilities. The highly effective solution provides business managers with a powerful suite of core business applications. The software is also most suitable for application in industries such as life science and healthcare, where regulations need to be regularly updated and strictly adhered to.

A comprehensive collection agency creates and maintains regulatory information that must be accessible to all decision makers who need it. This info must be managed in a systematic, manageable fashion so that it is available at the critical time when needed and easily accessed by interested parties. All regulatory information needs to be stored in an organized database so that all regulatory activities can be reviewed and analyzed for improvements in the future.

Regulatory information management solutions are best suited to the nature of the industry and nature of business, especially for the biotechnology, pharma, and clinical research industries. Thus, there is an increasing demand for regulatory information management solutions, owing to the increasing stringency of the norms by regulatory bodies such as the European Medicines Agency, Food and Drug Administration (FDA), and other agencies in the respective regions. Regulatory information management solutions streamline compliance and help organizations effectively report compliance practices to regulatory agencies.