Regulatory Information Management System (RIMS)
RIMS (Regulatory Information Management System) allows companies to team up, preserve application information data from various locations and enhance the processes of preparing a submission, as well as simplify the publishing and tracking of all regulatory activities that support a product’s complete life cycle.
Organizational regulatory information efforts begin with drug development to drug registration and commercial launch. Multiple divisions within a company are required to gather the regulatory data information required to supervise all processes in manufacturing, registering, and launching the drug. This information includes the design profile, ideas, technical information or specifications, and prototypes (if any). Many organizations currently keep and handle these operations using spreadsheets and paper records.
International rules and data standards in GMP environments evolve regularly. When Regulatory Information Management is done manually, its efficiency could be compromised, and this is a challenge for pharmaceutical, biotechnology, and other related industries. All material should be submitted electronically using a document management system as required by regulatory standards. Organizations must adopt new technologies to prepare ahead for future requirements.
AmpleLogic Regulatory Information Tracker is built on the LOW CODE AND NO CODE (LCNC) PLATFORM and comprises two modules: ANDA and DMF Tracker. This Pharmaceutical RIMS Software can help you improve the quality of your data, boost operational efficiency, decrease mistakes, and streamline communication across departments.