GxP Lifeline

Tips to Gain Executive Support for a Digital QMS


You’re a quality professional who understands the benefits of a digital quality management system (QMS). Now it’s time to get executive support and adopt the tools you need to improve efficiency, achieve a higher degree of quality, and streamline compliance.

It might be tempting to put together a strong case statement for support that explains all the ways a digital QMS would benefit the quality team. Resist the urge to do that. Instead, you have to build a persuasive case that speaks directly to the C-suite’s pain points, and when it comes to acquiring new technology, most executives are hesitant because they can’t see beyond the costs.

As you work to get executives on board, the most effective approach will be to quantify and communicate the importance of quality – and how investing in a digital QMS results in savings.

Quantify the Cost of Quality

You’ll need to start by quantifying the cost of quality, which gives you a strong start in speaking to executives about dollars and savings. Several models have been developed, including one created by well-known quality expert Philip B. Crosby, who argued that organizations choose to pay for poor quality, and his model supports that assertion. (1)

Whether you use the model created by Crosby or build your own, it’s critical that all costs are accounted for and calculated correctly. For example, a defect that is identified by a customer is typically seven to 10 times more expensive than the cost of preventing that defect. (2) In order to provide executives with a holistic view of quality costs, you have to factor in all relevant costs, which is why you should use an established model or be able to describe the rationale for how your model is structured.

Within the model you use, identify ways a digital QMS can contribute to improving costs. For example, after digitizing, a MasterControl customer reduced quality review time for an individual batch record from 2-3 hours to 10-15 minutes. Tangible efficiency improvements like that can have a significant impact on the bottom line.

Add Up the Soft Costs

While some costs don’t have a line item on the budget, these costs should still be quantified as much as possible. As just one example, you can demonstrate the impact of nonproductive time that is the direct result of not having a digital solution. Routine tasks like routing documents around the office or tracking someone down for a signature can slow the pace of work to a crawl. With a digital QMS, documents are automatically routed to the right person, and this frees up employee time to focus on work that improves efficiency and gets high quality products to market faster.

To calculate the soft costs, you could ask each employee to track the number of hours they devote to paper processes over the course of a week. You can use that figure to determine the number of hours spent pushing paper each year and multiply that number by the average hourly wage at your organization. This gives you a tangible figure to present to executives, and it may be higher than you think.

A MasterControl executive worked with a company that has 450 employees. They determined each of them spent three hours per week on paper processes. After doing the math, they discovered the amount of money spent on that work could be used to hire 30 additional people. For executives, these are compelling figures.

Offer Real-Word Examples

If a sticking point with the executives is that the current paper-based QMS is still working well, you can build a strong case by finding real-world examples of when a preventable human error cost a company far more than the expenses associated with implementing a digital QMS.

To illustrate the perils of a paper-based approach, you won’t have to look far. Emergent BioSolutions, a contract development and manufacturing organization was producing the Johnson & Johnson vaccine, but then 15 million doses were found to be unusable because of human error and documentation issues. (3) The cost of this mistake can be estimated by looking at the U.S. government contract signed by Johnson & Johnson. They agreed to provide 100 million doses for $10 each. (4) If the doses ruined by Emergent BioSolutions were similarly priced, the waste amounts to $150 million.

Find real-world experiences that speak to what it will cost if quality isn’t prioritized. Combined with your cost-of-quality model and your calculations for soft costs, you can create a strong case to convince executives it’s time to invest in modern technology. While they might express concerns about expenses, the real question is if the company can afford to jeopardize quality by not having a digital system.


  1. Cost of Quality,” American Society for Quality
  2. What Is Your True Cost of Quality,” James Wells, Quality Digest, March 2021
  3. Factory Mix-Up Ruins Up to 15 Million Doses From Johnson & Johnson,” Sharon LaFraniere and Noah Weiland, New York Times, March 2021
  4. Pfizer, Johnson & Johnson balk at shareholders’ push for COVID-19 vaccine pricing info,” Keven Dunleavy, Fierce Pharma, February 2021.

Dale Thompson - Profile Picture

Dale Thompson is a content marketing specialist at MasterControl’s headquarters in Salt Lake City, Utah. Her areas of expertise are pharmaceuticals and manufacturing. Thompson’s varied career includes extensive work in grant writing and journalism as well as crafting content to highlight the work of biology professors and paleontologists. She has a bachelor’s degree from Evergreen State College and a master’s degree in professional communication from Westminster College.

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