Ten years ago, the Food and Drug Administration (FDA) did an about-face in their approach to electronic records and signatures to encourage a broader adoption of new record management technologies.
Today, the entire US pharmaceutical industry remains skittish about adopting and using electronic record keeping systems. This stems from a number of early missteps made by the FDA when they introduced new requirements in the ‘90s, which had very poor results. The FDA has since changed direction on electronic records, but many firms are either unaware of that change or remain skeptical. This article examines how the FDA has reshaped its requirement on electronic record keeping and sheds light on what some medical gas producers are doing to take advantage of today’s more efficient ways of managing their FDA records.
... to continue reading you must be subscribed
