Calculating an ROI of Quality

Investing in quality early on can prevent poor performance and noncompliance in the long term, protecting patients, integrity of the data, the bottom line, and the financial health of your company.

– Judy Carmody, Ph.D., Carmody Quality Solutions

Why does ROI matter?

While a “culture of quality” may be the ultimate goal for GxP compliant companies, that may sound a bit abstract and amorphous to the C-suite executives who will need to be sold on any quality-related investments. Especially for emerging firms, a QMS upgrade needs to deliver a measurable return on investment (ROI), and one that can be demonstrated prior to purchase.

Companies that invest in intelligent quality will reap the business benefits inside and out.

According to Ed Morris, Managing Partner of the Morris Group, "What auditors want to see is that businesses have a Quality Culture in place and they are continuously investing in it and improving upon it." Learn more about Ed's insights regarding the ROI of quality:

Why invest in quality?

Don’t take our word for it: Read the FDA’s Case for Quality

Life Sciences companies can reduce costs and increase their profits by focusing on quality measures during design and production. This quality improvement approach pays dividends in customer satisfaction and provides significant competitive advantages. ”

Calculating an ROI of Quality: How QMS Investments Can Drive Revenue

An intelligent quality management system (QMS) will provide return on investment (ROI) in a multitude of measurable ways, including operational efficiencies, audits streamlining and the ability to access real-time data.

Our free eBook explains how to:

  • Calculate an ROI of quality including operational efficiencies, time-to-market for new products, audit and qualification processes, access to documents and data as well as improvements in product quality
  • Build a business case for an eQMS by benchmarking your current quality performance
  • Choose the right eQMS solution that will be able to grow and scale over time

ROI ebook

To help reduce drug shortages, we need manufacturers to sell quality – not just medicine.”

– Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (2019)

How do you build a business case for quality?

The first step to building a business case is to benchmark the company’s current quality performance. The company’s performance should be benchmarked internally, as well as against industry averages. The specific metrics to look at will vary from company to company, but may include:

  • Total cost of quality (systems and staff)
  • Audit and inspections observations
  • Product recalls and deviation rates
  • Supplier risk profiles


After calculating savings and potential revenue, the next step is to calculate costs associated with an eQMS. This includes more than the initial purchase, and it’s important to be intellectually honest in tallying up the costs of a new system.