Finding the ideal RIM solution for your team can be a challenging endeavor. With so many great options available, it can be tough to know which one is a smart choice for the present and future of your organization. That’s why we came up with six steps to help you choose the right RIM solution for your needs.
Previously, we wrote about two Regulatory Information Management (RIM) solutions, Veeva Vault RIM and Generis CARA. During our discussions, we provided details about those RIM solution functionalities and offerings as well as specific considerations when implementing each.
However, we still haven’t answered the big question, “Which system is right for me?” Throughout this blog, we will discuss key deliverables and activities you should incorporate to answer the question definitively for your specific needs.
Step 1: Document Your Business Needs
Take the time to document your business processes and activities before contacting any vendors. Identify compliance risks and areas of concern by interviewing key users. The following areas should be considered for both current and future needs:
- Submission Management: Tracking and managing submission content, as well as submission planning and tracking.
- Submission Publishing: Building compliant submissions and submitting them to health authorities via an electronic gateway.
- Submission Archiving: Storing and viewing the complete history of the regulatory submission.
- Registration Tracking: Managing product registrations and health authority interactions.
- Regulatory Intelligence: Tracking regulatory policies, strategies, and submission requirements to support product registrations and submissions in various markets.
All companies, regardless of their size, should clearly understand what business areas they should focus on, even if they have only one or two people on their regulatory team.
Step 2: Formalize System Requirements and Scenarios
Create a detailed list of system requirements for the applicable business areas listed above, including requirements such as:
- Content creation and versioning
- Lifecycles and workflows
- Searching and reporting
- Audit trail
- Regulation requirements (such as 21 CFR part 11/Annex 11)
Additionally, you should prepare specific business scenarios, also known as user stories, that each vendor should demonstrate. Consider scenarios based on your typical work, focusing on the risks and concerns identified in Step 1.
It is often challenging to develop this deliverable. Consider using the expertise and knowledge of a third party, such as Daelight Solutions, if you have never done this before.
Step 3: Document Your Integration Needs
One of the biggest concerns for Regulatory is the need to duplicate data from the source system to the RIM system. This is a common need when putting together a submission or complying with future IDMP data model requirements. Be sure to include existing regulatory solutions, such as publishing tools or external vendor solutions. Identify opportunities within your organization to reduce system inconsistencies by leveraging integrations. Each of your potential vendors should address this need.
Step 4: Document Your Data Migration Needs
Moving to a new system almost always requires a data migration step. To get the best time and cost estimates from potential vendors, you’ll need to provide them with specific details related to the content that needs to be migrated. Be ready to answer questions such as:
- How many documents do you have?
- Where are they currently stored?
- How do you manage the versions?
- Do you need to bring over all the documents and versions or a specific subset?
- In what formats are the documents?
- Do you need to archive submitted eCTDs?
- Do source documents also include a rendition that needs to be brought over?
- Is there an audit trail that needs to be maintained?
- Are there specific metadata/attributes that need to be maintained with the documents?
Gathering this information usually takes time, so it is advisable to begin as soon as possible. When you share this with potential vendors, ensure that they clearly specify the amount of time your team is expected to devote to migration. Depending on your team’s workload, your migration activities may be best handled by a third party, such as Daelight Solutions.
Step 5. Know Your Potential Vendors
Take time to research each potential vendor and their solutions. Gather key details such as:
- How long have they been in business?
- How focused are they on life science?
- What is their track record?
- How many implementations have they done like yours?
- Are they investing in the product? How often do they have new releases?
- Are they ISO 9000 certified?
- For hosted solutions, how do they ensure security, response time, and disaster recovery?
- What type of support model do they have?
Step 6: Attend Vendor Demos
Now that you have a clear understanding of your business requirements and system needs, it is time to look at potential solutions.
- Share your business needs, requirements, and scenarios with each potential vendor.
- Have each vendor respond in writing to your requirements to document how their solution meets your needs.
- Ensure that each demo is focused on your specific business scenarios/user stories.
- Ensure that your selection team attends all demos.
- After each demo, your team should meet to debrief and document their impressions on how well the solution meets your business requirements and system needs. Try to quantify this evaluation so that you can visually see where each vendor is stronger or weaker than the others.
This can be a lengthy and time-consuming process. Consider using the information you gathered from Step 5 and the vendors’ response to limit the number of demos to your top three.
Conclusion: The Selection Process
When you do your due diligence and incorporate these deliverables and activities into your selection process, you can confidently answer the question, “Which RIM system is right for me?”
Choosing a RIM solution can be a challenging and time-consuming process. If you would like assistance with any or all of these activities and deliverables, consider using a vendor like Daelight Solutions. Contact us to see how we can help you pick the ideal RIM solution for your present and future needs.