Darshan Singh

Darshan Singh

Author is a pharmaceutical quality and regulatory professional with more than 23 years in drug manufacturing. He holds an M.Sc. in Organic Chemistry and a Diploma in Pharmacy. He has served as Quality Control Head, Quality Assurance Head and Plant Head, overseeing all manufacturing operations. He is co-founder and regulatory consultant at Laafon Galaxy Pharmaceuticals. He writes on SOPs, manufacturing processes, Schedule M compliance and drug pharmacology, and checks each claim against pharmacopoeial and regulatory sources.
  • Joined: July 17, 2024
  • Articles: 233

ALCOA vs ALCOA+ vs ALCOA++: Which Regulator Says What

ALCOA, ALCOA+ and ALCOA++ data integrity attributes compared across FDA, MHRA, WHO, PIC/S and EMA guidance

The short answer ALCOA is five data-integrity attributes — Attributable, Legible, Contemporaneous, Original, Accurate. ALCOA+ adds four more (Complete, Consistent, Enduring, Available) for nine. ALCOA++ adds a tenth, Traceable, and is the form the European Medicines Agency uses for clinical-trial…