Making the Business Case for a New QMS Solution

As you go through this process, a vendor evaluation checklist can be an excellent tool to keep track of the different options and quickly compare them.

Once you’ve identified these stakeholders, get their opinions on the current QMS and their priorities for a new one. You may get some invaluable information on the team’s needs or hear a powerful anecdote for use when you’re presenting your business case to your executive team.

Creating this document should also help clarify the specific requirements you need from an eQMS, which will be invaluable during the vendor evaluation process.

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You’ll also want to show your department leadership and executive team that a new eQMS will provide measurable value to the company, and there will be a clear return on the investment in the software. You can frame this in a number of ways. For example:
• Fewer resources will be required to manage the new QMS, thus saving the company money—especially on expensive external support.
• The new eQMS will increase the speed at which you get high-quality products to market, generating more revenue for the company.
• It will also reduce risk related to noncompliance, which could be a high cost to your business. A warning letter from the U.S. Food and Drug Administration may require years to resolve, eating up precious resources.

Your situation may be unique, but for most medtech companies you’ll need to consider:
• Product development uses the QMS for updating design controls and documents.
• Quality uses the QMS for updating and approving SOPs.
• Regulatory affairs updates and approves protocols and reports within your QMS.
• Manufacturing uses your QMS to pull documents like the DHF.
• Executive management uses the QMS to approve SOPs.
• VP of quality will likely be your executive sponsor throughout this process, and you should keep them updated on any developments.

You don’t want to lead with the intricacies of the design control module but rather with the most important points of the business:
1. State the problem. Show why the current process does not work, and illustrate the key challenges with the current QMS.
2. Present the solution. Describe the specific benefits the new eQMS will provide to the company (e.g., improve speed, efficiency, and compliance, and reduce risk).
3. Vendor selection: Show how you evaluated the vendors and made the selection.
4. Investment required: Outline the total cost of the solution.
5. ROI: Share the detailed ROI calculation.

Make a list of the key people who should be kept abreast of what’s happening or will be actively involved in carrying out this process.

This step should really begin as soon as you decide you’re going to build the case for a new eQMS. Even if you’re spearheading the process, you need everyone who has a stake in this process to be involved.

This will be at the heart of your business case, and it should answer questions like:
• What are the challenges you face with your current QMS? How are these challenges affecting the business (e.g., wasting team members’ time on menial work)?
• How is the organization operating with the current solution, and how would a new QMS solution change operations for the better? What are the benefits of switching?
• How are you going to measure success? What metrics will you measure? What objectives and key results (OKRs) will you be tracking?

Think of this as less of an extra hoop to jump through and more of an opportunity to clearly distinguish a preferred solution from its competitors. Use the organizational challenges and opportunities that you previously documented to identify the solutions that will help you overcome those challenges and meet your objectives.

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3. Identify internal stakeholders and sponsors

6. Establish your transition plan

At this point, you’ve likely accumulated a mountain of documentation for this purchase. But to effectively present your business case to an executive team, you’ll need to be concise and clear.

This will be particularly important to executives who are stewarding the financial well-being of this business. It can be tricky to pull out an exact ROI because the benefits of a great eQMS accrue over time, but there are ways to calculate it.

At this stage, you’re laying the groundwork for your business case, answering questions like:
• What is your policy on vendor evaluation? How many quotes are you required to get?
• What is the current budget for your QMS? Will that need to increase for this purchase?
• Where in the current budget cycle are you? Has a budget already been approved for the coming year? Timing can play a large role in getting approval for a new QMS.
• What documents will you need to create as you begin building this business case?
• Whose final approval will you need for this purchase? Is it a department head? Finance? Will there be several people who need to sign off on this?

You can see how the examples above will potentially save the company money or generate more revenue. So you can tell your executives that the investment in an eQMS will pay for itself over time.

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Typically, engineers like to talk about the details: the base of the mountain of information, we can call it. But what your executives need to hear is the most important information—the peak of the mountain—that everything is building up to.

As you go through this process, a vendor evaluation checklist can be an excellent tool to keep track of the different options and quickly compare them. Here are 14 key questions you should be asking every eQMS vendor:
1. Is this eQMS built specifically for medical device companies?
2. Is this solution aligned with major national and international medical device regulations and standards?
3. If not, how much customization is required? What is the cost and timeline for that customization?
4. Is the QMS software simple enough to implement quickly, but robust enough to meet the needs of larger companies?
5. Are purpose-built capabilities for managing design controls and risk management fully integrated into the QMS?
6. Are turnkey workflows for all aspects of the quality system available out of the box?
7. Does this QMS ensure full traceability throughout the entire medical device life cycle?
8. Can this eQMS help my team achieve a truly paperless audit?
9. Do you have medical device experts on your customer success team?
10. How quickly can this QMS solution be implemented?
11. How will this QMS help you stay proactive and ahead of regulatory changes?
12. Is ongoing software validation included at no additional cost?
13. Is this QMS solution built with a secure, modern architecture?
14. What is the total cost of ownership (TCO) and return on investment (ROI) we can expect?

Turn that into an executive summary and a PowerPoint presentation, and be prepared to go into details if you’re asked questions about the solution. But if you’ve gone through the purchasing process step by step and done your due diligence, you may just find that getting a “yes” isn’t as difficult as you imagined.

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In fact, G2 recently gave Greenlight Guru the “Best ROI” award among QMS software solutions.

One of the best ways to bolster your business case is by focusing on ROI.

You can take a look at the estimated ROI for Greenlight Guru’s eQMS by using our free value calculator (based on the same independent study). You can input your company’s specific information, and the calculator will estimate the potential ROI of implementing Greenlight Guru. This is the type of analysis you can share with your executive team while making the business case.

One of the essential parts of any business case is defining your organization’s needs and clearly articulating the goals and objectives of your proposed solution.

2. Document your organization’s needs

There are a number of ways to structure a list of personnel, but a tool like a RACI chart (responsible, accountable, consulted, informed) may be useful to help you keep track of everyone and ensure you’re communicating well throughout the process.

4. Evaluate vendors and build the case for the solution you want

Published: Tuesday, August 1, 2023 – 12:03

First published July 6, 2023, on greenlightguru.