RIMS logo

RIMS

Centralized regulatory data management and tracking for global compliance, IDMP-compliant with audit trails.

Solution by Sarjen Systems
Visit website

Overview

RIMS (Regulatory Information Management System) by Sarjen Systems is a centralised, IDMP-compliant platform designed to simplify and manage regulatory processes for life sciences organisations operating across global markets. It provides structured workflows for data tracking, submission management, and compliance oversight throughout the product lifecycle, from registration through to approval.

By consolidating all regulatory data into a single platform, RIMS supports teams in tracking submissions, approvals, variations, and renewals, reducing manual errors and the time spent on compliance tasks. The system is intended to support data-driven decision-making, improve product lifecycle management, and contribute to faster go-to-market timelines and lower operational costs.

Key Features

  • IDMP compliant: The platform is built to meet IDMP (Identification of Medicinal Products) standards, supporting global regulatory requirements.
  • Pre-validated for faster implementation: RIMS comes pre-validated, reducing the time and effort required to deploy and qualify the system within a GxP environment.
  • Enhanced compliance management: The system provides structured tools to manage and maintain compliance with regulatory obligations across multiple markets.
  • Robust audit trail: A comprehensive audit trail is maintained to support traceability and inspection readiness.
  • Centralised data for improved decision-making: All regulatory information is held in a single repository, giving teams consistent visibility and access to support informed decisions.

Core Capabilities

  • Tracking of regulatory submissions, approvals, variations, and renewals in one centralised location.
  • Intuitive workflows designed to improve efficiency across regulatory processes.
  • Support for product lifecycle management from initial registration through to market approval.
  • Visibility and control over regulatory processes to reduce operational overhead.

RIMS is part of Sarjen Systems' broader portfolio of GxP-compliant solutions, which also covers clinical trial management, pharmacovigilance, eCTD dossier publishing, quality management, manufacturing, and supply chain management. The platform is positioned for pharmaceutical and life sciences organisations requiring a validated, globally compliant regulatory information management solution.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Regulatory Information Management (RIM)
Software type(s)
Workflow Automation
Deployment type(s)
Hybrid
Industry vertical(s)
PharmaBiotech
Development stage(s)
ClinicalPost-Market & RWEPreclinical / Pre-Market
Target user(s)
QA / Regulatory Affairs
Compliance standard(s)
GxPICH