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…

Many of the challenges inherent in developing regulated products fall into the realm of risk that manufacturers need to examine and mitigate prior to going to market. Numerous drugs and medical devices are recalled each year, which underscores the importance of risk management in product design, development, and manufacturing.

Controlling risk is an important requirement for companies developing regulated products. International standards and regulations include guidelines specific to enforcing product safety and risk management processes. The guidances leave the “how” of risk management up to the company. …

The recent brouhaha over AstraZeneca’s claims about the efficacy of its COVID-19 vaccine has reaffirmed how seriously regulatory bodies and government agencies take data accuracy. After the biopharma company issued a press release claiming its vaccine reduced symptomatic disease by 79%, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) shot back, saying that figure was based on outdated information that “may have provided an incomplete view of the efficacy data.” (1)Although the actual efficacy of AstraZeneca’s vaccine is believed to be only slightly lower (the NIAID still endorsed it as “very likely a very good vaccine”), the mistake…

The COVID-19 pandemic has taught pharmaceutical and biotech companies a profound (and sometimes painful) lesson: A business can only succeed if it has a digital infrastructure that supports the momentum of operations and processes when work must be performed remotely. In weathering the storm of a global crisis, pharma companies have learned how critical it has become to fortify existing infrastructures, ensure secure connectivity, and facilitate real-time collaboration among workers, partners, and vendors. The lack of robust remote access and virtual business process management and monitoring capabilities spelled doom for many pharma organizations over the past year.

Adapting to Volatile Times

In an industry…

The technologies that underpin health care have been evolving rapidly in recent years, helping to drive digital transformation in the life sciences. In 2019, approximately 86% of life sciences companies reported experimenting with new technologies, including artificial intelligence (AI), to drive innovation and better patient outcomes, and 84% of health care organizations had adopted at least one cloud-based digital health solution using clinical data. 1,2

In 2020, the COVID-19 pandemic brought to light the importance and acceleration of digitization. In fact, according to a McKinsey survey of global executives, the pandemic has accelerated the digitization of customer and supply chain…

The start of the new year was a sign of hope, more so than any other year in recent history. While everyone realized nothing would magically be fixed, we’re all crossing our fingers that 2021 will bring an end to the pandemic and the return to normalcy. For the most part. Hopefully, that’s in the not-too-distant future, but until then, most industries are still reeling from the pandemic. Nutraceuticals are no exception.

Not every niche of the industry is going through the same problem, though. Companies that use botanicals in their products are looking at severe shortages due to unforeseen…