Archives

First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples.  Both [...]

The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been [...]

International QMS compliance inspections of pharmaceutical and medical device manufacturers by the FDA and MHRA are on the rise. FDA & MHRA Increase Inspections Both the Food and Drug [...]