Category: IDMP Software

Outgrowing Spreadsheets

Outgrowing Spreadsheets? It’s Time to Switch Smarter. Switch to RIMS.

April 25, 2025

Still managing regulatory data with Excel sheets? You’re not alone — but it’s time to rethink that approach. While spreadsheets may have worked in the past, they’re not built to handle the complexity of modern regulatory affairs. Let’s talk about why it’s time to make the switch to a smarter, streamlined system like Sarjen’s RIMS. 

Why Spreadsheets Are Holding You Back 

Managing product lifecycles, approvals, variations, and submissions across global markets is tough enough — doing it in Excel makes it even harder. Here’s what might sound familiar: 

  • Data Disarray: Too many sheets, too many tabs, and endless version confusion. 
  • Manual Overload: Repeating the same data entry for different markets or submissions wastes hours. 
  • Compliance Concerns: Spreadsheets don’t come with audit trails, leaving you vulnerable during inspections. 
  • Lack of Insights: Numbers sit in rows — they don’t tell you the bigger story. 

RIMS: A Smarter Way Forward 

Sarjen’s RIMS isn’t just software — it’s a smarter, faster, more reliable way to manage regulatory information. It brings structure, automation, and visibility to your operations, so you can: 

  • Track the Entire Product Lifecycle: From development to discontinuation — all in one place. 
  • Streamline Approvals & Variations: Automate tedious tasks and keep regulatory changes under control. 
  • Plan Submissions Proactively: Never miss a deadline with built-in planning tools. 
  • Ensure Global Compliance: Manage multi-market data without duplicating efforts. 

Switch Smarter. Switch to RIMS. 

Reach out to us at sarjen@sarjen.com to make the smarter move today. 

Preparing for ISO IDMP Compliance. Upgrading RIMS to Meet Evolving Regulatory Requirements

March 13, 2025

Introduction: The Evolving Regulatory Landscape 

In today’s fast-paced pharmaceutical and life sciences industries, regulatory compliance is more complex and data-intensive than ever before. One of the most significant transformations is the global adoption of ISO Identification of Medicinal Products (IDMP) standards. Designed to improve the identification, exchange, and safety of medicinal products, these standards are reshaping how companies manage regulatory information. 

To stay compliant and competitive, companies must ensure their Regulatory Information Management Systems (RIMS) are equipped to handle IDMP’s stringent data requirements. Sarjen Systems’ RIMS is a comprehensive solution designed to help organizations navigate this shift seamlessly. 

Understanding ISO IDMP Standards 

The ISO IDMP framework consists of five core standards (ISO 11615, 11616, 11238, 11239, and 11240), covering everything from product identification to packaging and substance data. These standards are aimed at: 

  • Improving patient safety by enhancing product traceability. 
  • Facilitating global data exchange between regulatory authorities. 
  • Streamlining pharmacovigilance for faster response to safety issues. 

Regulatory authorities like the European Medicines Agency (EMA) and U.S. FDA are adopting these standards, making IDMP compliance a must for global pharmaceutical companies. 

The Role of RIMS in Achieving IDMP Compliance 

Traditional RIMS solutions may not be equipped to handle the evolving data structures and workflows required for IDMP compliance. Upgrading to an IDMP-ready RIMS is critical to: 

  • Centralize regulatory data for easier retrieval and submission. 
  • Ensure data consistency across various regulatory agencies. 
  • Automate reporting and tracking to reduce manual errors. 
  • Simplify product lifecycle management, from development to post-marketing. 

RIMS by Sarjen Systems: A Future-Ready Solution 

Sarjen Systems’ RIMS is designed to empower pharmaceutical companies to meet IDMP requirements effortlessly. Let’s explore how: 

  1. Seamless Data Management
  • Structured Data Handling: Supports structured data input for substances, products, organizations, and referentials (SPOR), ensuring accuracy and alignment with IDMP standards. 
  • Single Source of Truth: Centralizes regulatory data, minimizing duplication and ensuring consistency across different regions and regulatory bodies. 
  1. IDMP-Compliant Submissions
  • Preconfigured IDMP Modules: Ready-to-use templates aligned with EMA’s IDMP format, streamlining the preparation and submission of regulatory data. 
  • Automated Data Mapping: Ensures that product data matches IDMP requirements without manual intervention, reducing errors and accelerating submission timelines. 
  1. Integration Capabilities
  • eDMS and eCTD Integration: Connects seamlessly with electronic Document Management Systems (eDMS) and eCTD publishing systems, ensuring end-to-end regulatory data handling. 
  • Cross-Platform Compatibility: Easily integrates with existing systems like ERP and Pharmacovigilance databases to pull in product and substance data without redundant data entry. 
  1. Real-Time Compliance Tracking
  • Automated Validation Checks: Detects non-compliant data entries in real-time, preventing submission rejections. 
  • Status Dashboards: Monitors submission readiness, regulatory statuses, and version control for effortless tracking. 
  1. Future-Proof Technology
  • Regular Updates: Sarjen Systems continuously updates RIMS to align with evolving IDMP guidelines and international regulations. 
  • Cloud-Ready Architecture: Enables secure, remote access and data sharing across global teams. 

Why Upgrading to an IDMP-Ready RIMS is Critical 

Failing to upgrade your RIMS can lead to: 

  • Regulatory delays due to non-compliant submissions. 
  • Increased operational costs from manual data rework and resubmission efforts. 
  • Reputation risks from non-compliance penalties and product withdrawal. 

By choosing RIMS by Sarjen Systems, companies ensure smooth regulatory processes, faster time-to-market, and lower operational risks. 

Final Thoughts: Stay Ahead with RIMS for IDMP Compliance 

The move towards ISO IDMP standards is inevitable, and regulatory authorities worldwide are accelerating the transition. Companies that adapt early with a future-ready RIMS will enjoy streamlined processes, faster approvals, and greater operational efficiency. 

Sarjen Systems’ RIMS offers a comprehensive, user-friendly, and fully integrated solution to ensure your business remains compliant, efficient, and ahead of the curve. 

IDMP SSPL

What’s the Difference Between RIM and IDMP Data Management, and How Are They Connected?

January 20, 2025

As the pharmaceutical and life sciences industries grow, managing regulatory information has become more complex. That’s where systems like RIM (Regulatory Information Management) and IDMP (Identification of Medicinal Products) come in. While they both play crucial roles in regulatory compliance, they serve different purposes and focus on different aspects of data management. But how exactly do they differ, and how are they connected? 

Understanding RIM (Regulatory Information Management) 

RIM systems are designed to manage the complete lifecycle of regulatory information, including document management, submissions, approvals, and compliance. The primary goal of a RIM system is to keep track of all regulatory information, ensuring that companies can stay compliant with global regulations while preparing and submitting the necessary documents to regulatory agencies.  

With RIM, pharmaceutical companies can manage a wide range of regulatory processes, including product registration, labeling, pricing, and more. A good RIM system ensures that the regulatory data is organized, up-to-date, and easily accessible, making it easier to respond to queries from authorities and streamline submissions. 

What is IDMP (Identification of Medicinal Products)? 

IDMP, on the other hand, is a set of international standards developed by the European Medicines Agency (EMA) that focuses specifically on the identification and traceability of medicinal products. The goal of IDMP is to ensure that all medicinal products are uniquely identified and can be traced back across various markets, promoting better safety and compliance. 

IDMP data management involves capturing and organizing detailed information about pharmaceutical products such as their composition, marketing authorization details, packaging, and more. By adopting IDMP standards, companies can ensure their products are accurately identified, reducing the risk of errors and improving patient safety. 

The Connection Between RIM and IDMP 

While RIM and IDMP focus on different aspects of regulatory data, they are closely connected. RIM systems manage the broader regulatory information of a product, whereas IDMP focuses on the detailed product identification data required for compliance. In fact, RIM systems often integrate IDMP data management within their platform to provide a comprehensive solution for regulatory compliance. 

By combining RIM and IDMP, pharmaceutical companies can ensure not only that their products are identified correctly but also that all regulatory data is managed efficiently. This integrated approach reduces the risk of errors, enhances regulatory submission accuracy, and streamlines product registration processes. 

How Our Solution Helps 

At Sarjen, we provide a comprehensive RIM IDMP solution that helps pharmaceutical companies manage both regulatory information and product identification data in a unified system. Our solution ensures that the data is always accurate, organized, and compliant with the latest global standards. By using our platform, companies can stay ahead of regulatory requirements and focus on what matters most—bringing safe and effective products to the market faster. 

By understanding the difference and connection between RIM and IDMP, companies can make better decisions on how to manage their regulatory information effectively, ultimately improving compliance and reducing the risk of delays or errors in their submissions. 

In short, while RIM and IDMP serve different purposes, their integration is key to streamlined regulatory data management. Together, they help pharmaceutical companies stay compliant, reduce errors, and improve the efficiency of their regulatory processes. 

IDMP SSPL

Is Your Organization Ready for IDMP Compliance? Here’s How IDMP Software Can Help

December 4, 2024

As the pharmaceutical industry faces increasing regulatory pressures, ensuring compliance with IDMP (Identification of Medicinal Products) standards has become essential. But how can organizations streamline this process and ensure they stay ahead of regulatory changes? The answer lies in adopting IDMP software that simplifies the journey to IDMP compliance. 

What is IDMP and Why is It Important? 

IDMP standards were introduced to standardize how medicinal product data is structured and shared across global regulatory bodies. These standards enhance data consistency, improve patient safety, and simplify the regulatory approval process. For regulatory teams, IDMP compliance isn’t just about meeting legal requirements; it’s about ensuring data integrity, traceability, and readiness for global market access. 

With the growing complexity of international regulations, managing compliance manually is no longer feasible. This is where IDMP compliance software plays a critical role. 

How Can IDMP Software Help? 

Here’s how an effective IDMP software solution like Sarjen RIMS can streamline your compliance journey: 

  1.  Leverage Your Existing Data

IDMP software helps you start by identifying, cleansing, and integrating your existing data assets. This ensures you’re not reinventing the wheel but optimizing what you already have, making your transition to compliance faster and more efficient. 

  1. Automate Data Inventory and Cleansing

With automated data cleansing features, IDMP software reduces manual intervention, ensuring that your data is clean, structured, and validated for submission to regulatory bodies.  

  1.  Advanced Data Mining and Mapping

The software’s advanced data mining capabilities extract essential information from your regulatory documents and enterprise systems. It then maps and harmonizes this data to ensure it aligns with IDMP standards, improving accuracy and consistency. 

  1. Real-Time Data Validation

Ensuring data accuracy in real time is crucial for compliance. IDMP software validates data as it’s entered, reducing the risk of errors and rework, and ensuring your submissions are always up to standard. 

  1. Scalable and Flexible Integration

A good IDMP software solution integrates seamlessly with your existing systems like regulatory information management systems (RIMS) and enterprise resource planning (ERP), allowing for smooth, scalable compliance. 

Why Choose Sarjen RIMS? 

Sarjen RIMS offers a comprehensive IDMP solution that automates your workflows, validates data in real time, and ensures seamless integration with existing systems. With Sarjen RIMS, you can future-proof your regulatory compliance, ensuring your organization remains ready for any upcoming regulatory challenges. 

Ready to make your IDMP compliance journey easier? [Contact us today] to see how Sarjen RIMS can help you stay ahead. 

 Sarjen Systems is a trusted partner in digital transformation for the life sciences and pharmaceutical industries, with over two decades of experience delivering innovative regulatory and compliance solutions. Our mission is to empower organizations with technology that simplifies processes, enhances efficiency, and ensures global compliance.