What can happen when a laboratory doesn’t know that its electronic records leave a digital trace that the FDA can follow.
Behind analytical data are humans – with pressures, emotional and personal needs to provide the best possible data for the biggest impact, personal pride, or simply a desire to make their lives easier. Do human or cultural factors affect scientists in regulated laboratories or operators in manufacturing areas?
It’s not just about compliance any more. You’ve seen it in the headlines: 79% of Warning Letters issued by the FDA cite data integrity issues in 2016 (up from just 26% in 2013). But what… Read more >