Blog

ALCOA++: What’s New, What’s Important, and  What You Need to Know

Written by Willis Thomas | Apr 28, 2023 9:00:00 AM

The acronym ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate. It has been reported, that the term was introduced by Stan W. Woollen (Senior Compliance Advisor and Associates) in the FDA office in the early 1990's. Later, the European Medicines Agency (EMA) added four more requirements that focus on data management: Complete, Consistent, Enduring and Available.  This step of continuous quality improvement earmarked the name of ALCOA+.  

Most recently, Traceable has been added to this list, resulting in the new acronym ALCOA++ that should be used going forward starting now in 2023.