Editor’s note: When Lillian Erickson worked as global quality manager for MasterControl, she authored this creative post to help other parents who are quality professionals survive and have fun at Career Day.

When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain quality and what a quality manager does to 6- and 7-year-olds?

In my eight years in the quality field, I’ve hosted over 200 client audits and faced some of the strictest auditors. I’ve spearheaded six ISO audits, one of…


Because financial success hinges on digitization, paper-based processes need to be eliminated.

As reported by Deloitte, digitally mature companies are, “about twice as likely as lower-maturity ones to report net profit margins and annual growth significantly above their industry average.” (1) The substantial difference in revenue is attributable to the advantages that come with digitization, which includes being ready for change and moving on opportunities quickly.

Looking at paper-based processes specifically, there are five critical ways a lack of digitization hurts the bottom line.

1. Disconnected Processes

Paper-based processes mean disconnected processes, which can cost you. As just one example, the higher the…


Only a year ago, research examined the impact of COVID-19 on trends in biopharmaceutical industry and bioprocessing and found that “use of contract manufacturing organizations (CMOs) and other outsourcing will continue to accelerate.” (1)

More than 12 months later, this prediction is proving to be accurate.

CMOs and contract development manufacturing organizations (CDMOs) play a central role in making COVID-19 vaccines available throughout the globe, and this work coincides with meeting the rising demands in personalized medicine.

“Manufacturing capacity for cell and gene therapies was already strained before the pandemic, and now it’s under further pressure because vaccines use a…


If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout the entire product development life cycle — a responsibility which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around quality; you dissect it and measure it and evaluate it and analyze it; you sleep, eat and breathe quality. …


There are many measures proactive people take to prepare for potential disasters. Buying homeowner’s insurance, packing emergency “bug-out” bags, and storing viable supplies of shelf-stable foods are just a few common examples of preparedness contingencies. As recent events have shown, a lack of preparedness during a state of panic can lead to shortages of necessities like gasoline, hand sanitizer, and even toilet paper. To avoid similar distresses and business disruptions when outages occur in the systems that store and connect data, companies need their own disaster recovery and business continuity plans. …


In life sciences, we are rapidly approaching a time when the use of artificial intelligence and machine learning (AI/ML) will be an industry norm.

Just last year, an international team demonstrated the AI system they developed is capable of detecting breast cancer, and in some instances it outperformed medical experts. 1The technology is not yet ready for clinical use, but its success illustrates the potential for AI to elevate our work as we strive to improve and save lives.

The impact of AI will be enormous, and the only thing that looms larger is our obligation to be responsible about…


New technologies are enabling innovative advances in precision medicine, or personalized medicine. They are also generating vast amounts of data — across clinical studies, laboratories, patients, products, and more. As more enormous, disparate data sets are created, organizations need to be able to track, store, and analyze the information quickly and accurately.

To fulfill the promise of precision medicine, organizations must harness all that data through greater connectivity and interoperability, increased visibility, and more data-driven insights.

“As in other domains of data science, the availability of digital data is key to precision medicine,” according to a Deloitte report on cognitive…


The global business disruption caused by COVID-19 has exposed weaknesses in manufacturing, such as conducting audits remotely or adapting to supply chain instability, as well as production pains caused by paper. Altogether, the pandemic created a sense of urgency around accelerating efforts to digitally connect areas of operations that are still offline/disconnected.

According to a McKinsey survey of global executives, the pandemic has accelerated the digitization of customer and supply chain interactions and of internal operations by three to four years.1

As manufacturers continue to work through COVID-19 challenges and beyond, they must focus on ensuring workforce safety and productivity…


There is a tendency in the quality management field to confuse the root cause of a problem with the problem’s real cause. A root cause is objective evidence of a quality problem. The real cause of a quality problem, however, is the actual finding or nonconformance.

Uncovering real causes of quality problems requires different, deeper scrutiny than identifying root causes. Mistaking one for the other can lead to the perpetuation of cycles such as this one:

  1. A severe quality problem occurs at a production facility after a change is made.
  2. A team of stakeholders and possibly consultants convene to investigate…

Editor’s note: This is part one in a two-part series. The second installment can be found here.

What do these different products have in common?

  • Bone volume computer-assisted reading (VCAR) software used to support clinicians in the review of spinal images (GE Medical Systems)
  • ProFound AI Software for breast density detection via mammography (iCAD)
  • BrainInsight for automatic labelling and measurements of Neuroradiology MRI images (Hyperfine Research)

These products all claim to use Artificial Intelligence/Machine Learning (AI/ML) software technology to solve medical challenges. They are all medical devices on the market that have been cleared by the U.S. Food and Drug…

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