By: Daniel R. Matlis, President
Vast Amounts of Process and Product Intelligence Go Unused
Life science companies are obsessed with collecting dumb data. We assemble it, retain it, and hoard it to support regulatory and legal requirements.
But what happens to these vast amounts of collected data? Unfortunately, most of the data is “lobotomized” as soon as it hits the paper it was printed on or the electronic document it was saved to — vast amounts of product and process intelligence that could be used to improve control over manufacturing and product quality go unused.
FDA intends to drive life science companies to harness some of that intelligence. The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) provides FDA with the ability to conduct electronic inspections (e-inspections) and target onsite inspection based on quality metrics.
Read the rest of the article in Pharmaceutical Online.