Regulatory Information Management (RIM)

RIM Module for ARAS PLM

Regulatory Information Management (RIM) is a crucial component of the compliance strategy for companies in regulated industries such as the pharmaceutical, medical technology, and biotechnology industries. A RIM system enables efficient management and tracking of all regulatory requirements, documents, and deadlines necessary for the submission and approval of products to authorities worldwide.

Integrating a RIM module into a PLM (Product Lifecycle Management) system, such as ARAS PLM, creates a seamless connection between regulatory requirements and product development. This promotes more efficient collaboration and faster market access.

Key Features:

• Regulatory Compliance: Seamless management and tracking of regulatory requirements and deadlines for global markets.
• Document Management: Efficient filing and management of all regulatory documents such as approvals, change requests, and declarations of conformity.
• Product Lifecycle Management: Integrated monitoring of the regulatory status throughout the entire lifecycle of a product, from development to market withdrawal.
• Authority Communication: Direct management and documentation of communication with authorities and approval bodies (e.g. FDA, EMA, local health authorities).

Benefits of the RIM module in ARAS PLM:

• Compliance with international standards: Support for different requirements in various regions and countries.
• Central information platform: All regulatory data, documents, and workflows in one place, linked with other modules in the PLM.
• Improved transparency and control: Real-time overview of the status of submissions and approvals, automated notifications for important deadlines.
• Audit and reporting functions: Complete traceability and comprehensive reporting for internal and external audits.

Visions of the Future:

• Integration of Artificial Intelligence to assist in the submission of documents and the analysis of regulatory requirements.
• Automated submissions for EUDAMED and other central authority portals.