On April 2, 2026, the FDA issued a warning letter that should be on the desk of every Quality leader in life sciences. It cites several familiar deviations — but embedded in the findings is something ...

In highly regulated industries such as pharmaceuticals and biotechnology, manufacturing is about much more than producing a product. Companies must prove through clear documentation and testing that ...

AI is no longer a future concept in lifesciences, it’s actively being deployed across business processes from regulatory submissions to manufacturing monitoring to quality operations. But while ...