The clinical trials enterprise has long assumed that when it comes to ensuring trial quality, data is king and more is better. Not only was it considered essential to gather detailed data on every aspect of a clinical trial, but that data had to be double-entered, checked, queried, cleaned, and validated.
Quality risk management (QRM) is not a concept to be applied in a vacuum. Rather, it is a discipline that provides the most value when used throughout the product life cycle.
Ever-increasing amounts of data generated throughout the product life cycle can be hard to utilize to the organization’s advantage because of silos, misalignment, and complexity.
In writing my last article about whether the life sciences industry has driven out people’s ability and motivation to think, I was reflecting on one of the most insightful comments I ever received. I had given a good manufacturing practice (GMP) refresher session in a company whose mantra was efficiency and speed. This led to a variety of process and cultural issues, because the desire for speed led to broken systems loaded with Band-Aids, corners being cut, people making mistakes, and more — which in turn created a poor quality culture within the company and led to deviations, scrap, and other problems.
Successful implementation of quality by design (QbD) can lead to significant revenue growth and margins from the shortened development cycle. However, in our recent reports on the state of ICH Q8-11 guideline adoption in the industry, we confirmed that, despite the sound rationale of the new operating paradigms, industry uptake has been slow since the publication of the guidances nearly a decade ago.
Without an outcomes based approach where you are ensuring training effectiveness, your employees’ performance will continue to suffer and so will your quality.