3 signs that you need to create a culture of compliance As mentioned in my first post on data integrity, people trust that companies create safe, quality products and rely on data to support that… Read more >
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 >
Bioanalysis of Antibody Drug Conjugates in the Spotlight Few, if any, of the joggers along Boston’s Charles River could have realized the anticipation contained within the Hyatt Cambridge on a recent September Sunday morning. In… Read more >
In August 2014, the United States Pharmacopeia and the National Formulary (USP-NF) put into effect new guidelines to “allowable adjustments” in its Chapter <621> (USP37-NF32 S1). And as of August 1, 2016 when USP 39… Read more >
Compliance is required by every regulated industry and in nearly every nation. Whether it’s complying with strict regulations from the United States Food and Drug Administration, the European Directorate for Quality Medicines, or other regulators… Read more >