Why implement a RIM?

Implementing a RIM system is essential for the regulatory compliance of pharmaceuticals and medical devices. Regulatory departments ensure products meet regulatory requirements and compliance standards, including the approved product information. 

Managing data in a RIM system is critical to ensure regulatory data’s accuracy, integrity, security, and compliance. Effective data governance involves a combination of policies, processes, and technologies. 

We recognize that a RIM system is not a “one-size-fits-all” model and must account for variables such as company dynamics and future requirements. The system must be able to connect different departments and be user-friendly enough to support effective data compliance. 

What is IDMP, and why is it important?

IDMP, or the identification of medicinal products, is an international standard for identifying and exchanging information about medicinal products. It was developed to improve the consistency and accuracy of data related to pharmaceutical products and to facilitate the exchange of information between regulatory authorities, the pharmaceutical industry, and other stakeholders. 

What are the benefits of implementing a RIM system?

  • Improved pharmacovigilance and drug safety by enhancing the ability to track and trace medicinal products
  • Streamlined regulatory processes by standardizing data submissions and reducing redundancies
  • Better exchange of product information among regulatory authorities, healthcare professionals, and other stakeholders
  • Enhanced interoperability and data quality for medicinal product information
  • Improved consistency and accuracy of medicinal product data across various jurisdictions 

What are some of the challenges you may face when employing a RIM system?

  • Implementing IDMP standards can be complex and resource-intensive for pharmaceutical companies.
  • Regulatory authorities must adapt their systems and processes to receive and utilize IDMP-compliant data.
  • Standardizing existing data stored in different formats or systems can be challenging.
  • IDMP is an essential initiative in the pharmaceutical and regulatory fields to enhance medicinal products’ quality, consistency, and safety through standardized data management and exchange. It is expected to continue evolving and expanding in its adoption in the coming years as more regulatory authorities and industry stakeholders embrace the standards. 

PLG supports clients with the following RIMS services:

  • RIMS end-to-end implementation (assessment, configuration, migration, change management, training, implementation, and maintenance)
  • IDMP standards implementation (from the scoping phase to support for a long-term implementation)
  • Data entry and migration support to the RIM system 

Benefits for clients who choose PLG as their partner for RIM support:

Knowledge and expertise are significant factors in considering us as your RIM partner. There are many different RIM systems in the market, and no perfect system exists for all clients. We have experience with most systems in the market. After thoroughly analyzing your existing data and plans for company expansion, we can suggest the best options for you.  

Our experts are RIM specialists but also life science experts. We are multi-competent, and this is where we can provide total value with a holistic overview of the system, coupled with an eye for detail. 

We have supported our clients in IDMP transformation and RIM system implementation since 2013.

PLG has a pool of more than 15 RIM–experienced consultants delivering multiple activities around RIM systems, EDMS, IDMP, data governance 

Numerous projects of: 

  • RIM selection support
  • RIM implementation and maintenance
  • IDMP awareness
  • IDMP gap analysis (readiness assessment)
  • IDMP compliance implementation
  • Data governance setup and implementation
  • Knowledgeable with Veeva, Ennov, Aris Global, Extedo, and many other tools
  • Strong consulting mindset with project and change management skills 

IDMP is the future of the pharmaceutical world, a data landscape that will enhance patient safety, accelerate time to market, and the visibility of drug shortages.

Gregoire Mouton

RIM Team Lead, ProductLife Consulting

Gregoire Mouton