Navigating Pharmaceutical Data Management: ISO IDMP with RIMS and eDMS

by Andrea Bartolomei, Regulatory Digital Transformation Manager @PQE Group

One of the major challenges that pharmaceutical companies will face in the coming years is the updating and maintenance of company databases with correct and complete information in accordance with the new ISO IDMP requirements. This is necessary to obtain marketing authorization for their products in various international markets or to comply with the requirements of various regulatory bodies (primarily the EMA) for already authorized products. The goal set by the EMA is to improve the quality and reliability of medicinal product data through the SPOR (Substance, Product, Organization, Referential) project, which involves the adoption of the international IDMP (Identification of Medicinal Products) standards developed by the International Organization for Standardization (ISO). Other regulatory bodies are considering adopting these standards, including Swiss authorities, who are prioritizing the project with potential alignment to some of the EMA requirements, and US and Japanese authorities, who are part of the Global IDMP Working Group and are therefore likely to align with these standards soon.  This translates into the need for various companies to promptly undertake a review of internal processes that allow for the standardized and consistent collection and management of information.

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Beyond the imperative need to start the alignment process with the new requirements, the medium to short-term benefits can also be significant at the corporate level.  For instance, how many times have we needed to quickly and accurately retrieve information? Having harmonized and easily accessible data, along with the possibility of creating a rapid and reliable reporting system, facilitates the analysis of the data itself. Such an advanced analysis and reporting tool helps the potential user make informed and strategic decisions based on accurate and up-to-date data. 


eDMS and RIMs System Overview 

In recent years, to provide pharmaceutical companies (and others) with the right tools to face these challenges, many providers have developed various solutions represented by Regulatory Information Management Systems (RIMS) and electronic Document Management Systems (eDMS). These are two essential tools that are revolutionizing the way companies manage their regulatory activities, registration data, and related documentation.  Although these two types of systems have very different functionalities and purposes, they are interconnected and, through synergistic work, allow for the optimization of activities with a significant impact in terms of time and costs. Let's look at them in detail. 


Regulatory Information Management Systems (RIMS) 

A RIMS is designed to manage, track, and archive regulatory information about pharmaceutical products and more. This type of system offers several important advantages, such as helping companies maintain compliance with ever-evolving regulations, which translates into a reduced risk of non-compliance. Through better traceability and monitoring of regulatory processes, it is possible to have a clear view of the status of applications and assigned tasks, the currently authorized information, and to optimize the planning activities of the various Business Units. A RIMS helps automate and centralize regulatory information: having automatic mechanisms for collecting and processing information optimizes the resources needed to prepare, submit, and monitor regulatory applications. With the advent of ISO IDMP requirements, this type of system assists in the conversion, management, and submission of data related to a specific medicinal product in the ISO IDMP compliance format (as is already happening at the European level with the EMA). This also leads to advanced reporting and analysis capabilities, which allow for generating detailed reports on regulatory activities, monitoring performance, and identifying areas for improvement. 


eDMS (electronic Document Management System) 

Different in structure and purpose is an eDMS (electronic Document Management System). This type of system is a software platform used to create, manage, approve, store, and retrieve electronic documents, improving accessibility and information sharing.  The main advantages of an eDMS are the ability to have easy access to documents and to trace the history of a specific document. Through this type of system, it is possible to reconstruct the version history of a document, retrieve previous updates, and track actions performed on the document itself. Practically, this solves the problem of tracking the latest version of a document, with the latest version being identified as the current one. eDMS systems include workflow management features, which allow for the automation of document review and approval processes and track the latest approved version, facilitating the search for documents using keywords, metadata, or pre-set and customizable search engines within the system itself. By integrating a RIMS with an eDMS, companies can automate many processes. For example, documents created and managed in an eDMS can be automatically linked to regulatory submissions managed in a RIMS. The preparation of submission packages is managed through publishing tools, which allow for the preparation of sequences (packages) in various electronic formats such as eCTD, NeeS, VNeeS, etc. Having an integrated publishing system with a RIMS and an eDMS offers several significant advantages in the context of regulatory information and company document management, making the various workflows smoother and more automated. For example, it can significantly reduce the need for manual data entry and minimize the risk of errors. This leads to greater operational efficiency and time savings, with increasingly consistent and accurate data being reused by the RIMS.  In summary, integrating a publishing system with RIMS and eDMS offers numerous benefits, making business processes more efficient, secure, and compliant with regulations, facilitating collaboration, and supporting more effective information management. 



Having digitized processes means using digital tools and technologies to automate and optimize business activities, improving efficiency, reducing errors and costs, and facilitating real-time data access. This leads to more agile, transparent, and responsive market management. In this perspective, the new publishing tools, regulatory information management systems (RIMS), and electronic document management systems (eDMS) are essential tools for pharmaceutical companies operating in an ever-evolving environment, where increasingly the digitization of regulatory processes, and beyond, is a crucial point. Indeed, transforming, maintaining, and exchanging regulatory information in perfect accordance with a common language, such as ISO IDMP, can lead to success in submission or become a difficult obstacle to overcome if data management is not carried out precisely and promptly. 


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