The business case for an eQMS: how to gain management support

How to get your management team to say “Yes” to an eQMS 

As a quality professional, you know the value of an eQMS. You’re aware of the drawbacks of manual or paper-based systems and how an eQMS can enhance speed, safety, and efficiency in your organization.

Perhaps you’ve already identified the ideal eQMS that aligns with your needs and are eager to make the purchase. But here’s the challenge - you must secure approval from your executive management team. 

First things first, don’t assume they share your enthusiasm or understanding of an eQMS - the reality is that they may not even be familiar with the concept. To gain their approval, you must build a convincing business case that highlights the problems that need to be addressed and shows how your proposed eQMS solution will effectively resolve them, offering an attractive return on investment.

Given the significant financial commitment involved, you’ll need to present your case persuasively—think of yourself as a salesperson. While this may feel outside your comfort zone, we’ve created this guide to help you effectively convince your executives to say “Yes” to your eQMS investment.

Put yourself in the shoes of your management team 

While you may want to implement an eQMS to improve your CAPA handling, streamline your audit process, or put an end to manual chasing of employees who are overdue on their training tasks - here, we’re talking about your pains as a quality professional - and not your CEO’s. Therefore, these problems that YOU need to solve will not resonate with your executive team. 

The key to convincing your top management team is flipping your approach and answering the question: how is an eQMS going to solve THEIR problems? 

Remember, your pains and priorities are not the same as your organization’s executive teams’. The leaders at your company have many competing priorities; they’re playing a delicate balancing game of speed and bringing innovative, safe products to market while controlling the costs of running the business. 

If budgets are tight, will they consider an investment into something that doesn’t increase revenue or cut down on costs? 

That’s why you shouldn’t be disheartened if your CFO does not immediately see the financial benefits and return on investment of an eQMS. The only way to get your management team’s attention is by presenting an impressive business case, which we will teach you how to create.

How to translate the value of an eQMS to your executive team

Securing approval from your C-suite requires a strategic approach that aligns the benefits of an eQMS with the financial and operational goals of the company. 

As already mentioned, the focus here is on the direct benefits for the executive team i.e. the entire organization and not just the quality department. You must translate the technical advantages of an eQMS into a language that resonates with executives.

While the biggest concerns of your executive team can vary depending on your industry and organization size, there are some key worries that consistently keep life sciences leaders up at night. Here are the most pressing ones:

• Financial performance and shareholder value
• Innovation and Research & Development
• Ensuring regulatory compliance and quality assurance 
• Market expansion and globalization
• Digital transformation and implementing AI technology
• Operational efficiency and cost management 
• Reduce time-to-market
• Talent acquisition and retention 

Ultimately, all top management worries boil down to the company's financial health, survival, and long-term prosperity. A longer time-to-market is expensive in the same way that non-compliance fines from the FDA are. Your top management will welcome with open arms any tool that helps them minimize compliance risks and maintain high levels of productivity. This means you have to effectively tell the story of how an eQMS will do that. 

But before you present your business case, there is a series of steps you must follow to ensure success. Read on to find out! 

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Bonus resource: Help your management team understand your QMS investment. Our blog clearly explains all things QMS and eQMS in executive-friendly language—perfect for sharing with your leadership team!

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Assess your organization’s current processes

While you may know why you need an eQMS, that doesn’t mean your executive team does. Start by identifying your company’s current processes and determining whether or not they’re cost-effective and how these challenges that you’re experiencing are affecting the wider organization.

Here are some common, inefficient practices you might recognize and how they are negatively impacting the business: 

• Dependence on paper-based reports and physical archives
  (Leads to increased operational costs, slower access to information, and a higher risk of data loss or damage)
• Disparate electronic file storage across departments
  (Wasting team members' time on tedious work, reducing productivity, and increasing the likelihood of errors due to inconsistent data)
• Evidence of redundant efforts in risk management and audits
  (Results in wasted resources, higher operational costs, and potential inconsistencies in data and reporting)
• Misalignment of corporate governance systems with key functions
  (Causes inefficiencies, miscommunication, and potential compliance issues, leading to increased risk and reduced effectiveness of governance)
• Disconnected Quality, Risk Management, and Financial Systems
  (Leads to siloed information, making it difficult to have a comprehensive view of the business, which can hinder strategic decision-making)

For each of these inefficient processes, ensure that you explain how an eQMS solution would change operations for the better and provide measurable value to the company. Here are some examples of how you can frame this: 

Greater efficiency: The new eQMS will require fewer resources, reducing the need for expensive external consultants and saving the company money.

Reduced risk: The eQMS will mitigate risks related to non-compliance, avoiding costly regulatory warning letters that could take months to resolve and drain valuable resources.

Improved speed: It will help the team bring high-quality products to market faster, increasing revenue for the company.

Collaborating with your finance team to quantify the financial impact of inefficiencies is a powerful strategy to convince top management to invest in an eQMS. By identifying adverse events from the most recent fiscal year linked to process gaps, you can assign a tangible cost to each inefficiency. For example: 

• Last year, our inefficient quality management processes contributed to a 35% increase in customer complaints, potentially costing us $120,000 in lost sales and refunds.
• Last year, 25% of our audit reports were either incomplete or duplicated, resulting in compliance risks that could cost us up to $200,000 in potential fines.
• In the last year, we spent an estimated 1,200 hours searching for and verifying data across siloed files, equivalent to over $100,000 in wasted labor costs.

As you can see from the examples above, these improvements have the potential to save the company money and generate additional revenue. Once you have quantified the costs associated with the inefficiencies in your company, presenting these figures to the C-suite will get the attention of your executive management team. Why? Because you're demonstrating a problem that is wasting money and resources - which needs to be addressed.

Evaluate your vendors

When choosing a vendor for your new electronic Quality Management System (eQMS), your company will likely require a formal evaluation of multiple options, including gathering quotes from different vendors. Even if you have a strong preference for a specific solution, conducting a comprehensive vendor evaluation is crucial for building a robust business case.

Think of this process not as an extra hurdle, but as an opportunity to clearly highlight the advantages of your preferred solution over its competitors. Use the challenges and opportunities you've previously identified to select solutions that will effectively address these issues and meet your objectives.

The resource below will support you in selecting the right solution by asking your vendors the right questions!

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Recommended learning: Learn what to ask your potential vendor to make sure you’re investing in the right solution for you.

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Determine your ROI

One of the best ways to strengthen your business case is by highlighting the Return on Investment (ROI). This aspect is especially crucial for executives focused on maintaining the financial health of the organization.

While it can be tricky to pinpoint an exact ROI—especially with something like an eQMS, where the benefits build up over time—there are ways to estimate it. At Scilife, we have a handy calculator that helps you figure out your potential savings, making it easier to present a solid case to your executive team.

Benefits of an eQMS that your executive team will be interested in

As a quality professional, you recognize that an eQMS provides numerous advantages that enhance business excellence, including increased productivity, improved quality compliance, and a stronger competitive advantage. Now is the time to communicate this to your executive team!

Here are the benefits of an eQMS that your executive team will be interested to hear about:

By presenting a clear business case that outlines the specific benefits, costs, and return on investment, you can effectively communicate the value of an eQMS to your management team, increasing the likelihood of receiving their approval. 

Building and presenting your business case

When presenting to your top management team, it's crucial to focus on the key points of the journey rather than the specific paths taken to get there. Quality professionals often like to go into detailed routes and technical specifics, but what executives truly need is a clear view of the final destination and the key milestones along the way.

Here are the key points to address:

1. Identify the problem: Start by outlining the current obstacles in the process, illustrating why the existing Quality Management System (QMS) is ineffective and the challenges it presents for the business.
2. Propose the solution: Clearly articulate the benefits of adopting a new electronic Quality Management System (eQMS), such as increased speed, enhanced efficiency, and improved compliance. You should also explain the journey taken to evaluate potential vendors, detailing the criteria used to select the most suitable partner for the organization.
3. Financial overview: Provide a clear outline of the total investment required for the implementation of the new system. Share a detailed analysis of the expected ROI, illustrating how this investment will yield significant benefits for the company.

Tips for persuading management to adopt an eQMS

1. Prepare a compelling presentation: Develop an executive summary and a PowerPoint presentation that succinctly conveys the key benefits and strategic importance of the eQMS. Be ready to dive into details if questions arise about the solution. 
2. Highlight specific benefits: Be prepared to answer "What's in it for us?" by clearly articulating how an eQMS will benefit your company specifically.  Don’t just say that an eQMS will improve supplier relationships; give an example of how your QMS can improve one of your troublesome suppliers. Use concrete examples, such as improving relationships with a problematic supplier, to make the benefits tangible and relatable.
3. Address the dreaded "Why now?" question: Management might like the sound of the benefits but may not see the immediate need to act. Your role is to highlight why this decision can't be delayed. Are there regulatory changes and compliance deadlines that must be met? Have there been quality challenges or close calls that could have resulted in serious consequences? Is your organization growing, and does it need to scale effectively with technology? In addition to showcasing the benefits, leverage these current weaknesses to underline the critical need for an eQMS now.
4. Find an ally: Identify and engage with someone in or close to top management who sees the value in an eQMS. This could be the head of finance, interested in reducing risk, or a marketing manager who views it as a selling point. An ally can help champion your cause and provide insights into management priorities.

These strategies will help you effectively communicate the value of an eQMS to your management team, increasing the likelihood of gaining their support.

Conclusion

Obtaining executive approval is just the beginning of your eQMS acquisition process. The next phase, implementing the eQMS, can present its own set of challenges. Therefore, it's crucial to collaborate with a partner who can develop a tailored implementation strategy and support you throughout the process of getting your new eQMS up and running. 

The great news is that Scilife's Smart QMS offers a flexible eQMS solution with an outstanding onboarding experience. Our team will support you every step of the way—from presenting your case to post-implementation—ensuring everything runs smoothly while keeping you informed about new features.