Distance runners know that the first objective of a race is to complete it, and the second is to respect the integrity of the course. Then they work backward from those two objectives to prepare for pace, considering variables such as weather,...
The old joke is that you can do anything with software if you have enough money. With an army of programmers, it was basically true. But now there is a new way to develop software quickly and with much lower investment: low code/no code...
When I hear biotech and pharma executives talk about their company’s “data estate,” I know the Microsoft and Amazon people have been meeting with them. I also think of the little British man who ran the estate on Magnum PI. His shtick was to be...
If you produce products in pharmaceuticals, nutraceuticals, or biotechnology, your organization must maintain system validation. The FDA defines this as “establishing documented evidence that provides a high degree of assurance that a...
In 1997, the FDA enacted regulation 21 CFR Part 11, which outlines how FDA regulated industries must handle electronic signatures and electronic records. This regulation sets the standards that must be met by pharmaceutical, medical device, and...
Pharmaceutical, Medical Device, and BioTech companies are required to detect and react to non-conformances and ensure that appropriate actions are taken to correct and prevent future occurrences. Still, more than half of the FDA Form 483...