RIM Implementation Challenges: How to Deal with Them

Implementing Regulatory Information Management (RIM) systems is often challenging. Some challenges you may face include data standardisation, system integration, regulatory compliance, global harmonisation and ensuring effective communication between various stakeholders involved in the regulatory process. Here are some strategies to deal with these challenges:

1. Identify key stakeholders and engage them early to understand their requirements.
2. Conduct a comprehensive assessment of your organisation’s processes and systems to identify gaps.
3. Establish a cross-functional team with subject matter experts to oversee the implementation.
4. Develop a detailed roadmap and implementation plan, breaking the process into manageable phases.
5. Ensure regulatory compliance by staying updated on regulations and incorporating compliance checks.
6. Standardise data formats and integrate systems for seamless data management.
7. Implement change management strategies and provide comprehensive training.
8. Continuously evaluate and improve the system’s performance.
9. Engage with vendors and industry peers for insights and best practices. If needed, seek external expertise.

Remember that RIM implementation requires ongoing commitment, collaboration, and adaptability. By addressing challenges proactively and leveraging the right strategies, you can overcome obstacles and achieve a successful RIM implementation in your organisation.

A recent look at PLG’s client RIM Implementation challenges

PLG recently engaged with a multi-national client to support them with RIM implementation. The client faced several challenges, including:

1. They suffered from disorganised collaborative work with partners with no end-to-end processes or integrated secured platforms to work within.
2. ​Lack of Global Data Governance leading to example, risks of non-compliance for variations impacting labelling.​
3. There were several regulatory challenges in collecting & storing Regulatory Information from Health Authorities. ​
4. The client was severely behind the technology trends of having a state-of-the-art RIMS solution. ​
5. They had no overall Digital Connectivity among the facets of the Pharma Industry (Links among Artwork, QMS, PV, Supply Chain Promotional Materials etc.)

​RIM Implementation solutions provided by PLG

ProductLife initiated the project by building a strategic roadmap with supporting business cases for the next five years. With the plan in place, PLG were responsible for:

1. Creating new records (e.g. new IND submission, new variations, renewals etc.)​
2. Updating existing regulatory records and data in line with information provided by regulatory stakeholders (e.g. approval date, marketing date, indication update etc.)​
3. Performing Data Quality Checks and Validation.
4. Upload regulatory documents to the client’s Document Management Software and link them to the related regulatory record in the Regulatory tracking system​.

The impact of solutions on the client

As mentioned, RIM implementation and use is a continuous improvement process, and the project is ongoing. There have been significant improvements among the client and partners, with higher working efficiency with the execution of end-to-end processes in place. There have also been lower levels of non-compliance in labelling variations. The client now has a platform for Digital Connectivity among the different working groups within the company, again leading to improved internal efficiency.

ProductLife Group’s RIMS team can and will support you during the implementation of your RIM system, helping you to overcome any challenges thanks to the expertise of our experts and their understanding of the risks involved in such an implementation.