Darshan Singh

Darshan Singh

Author is a pharmaceutical professional who is Master in Science (Organic Chemistry) and Diploma in Pharmacy. He has rich experience in pharma manufacturing sector, He Served in many companies as Quality Control Head, and Quality Assurance Head, along with Plant Head supervised all manufacturing processes. He is keen to research of pharma product manufacturing and drugs pharmacology. He is writing on several topics about pharmaceutical products, processes, and SOPs.

ALCOA+ Demystified: The Ultimate Framework for Data Integrity in Pharmaceutical Compliance

alcoa+

ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) is a globally recognized framework mandated by regulatory bodies like the FDA, WHO, and EMA to ensure data integrity in the pharmaceuticals manufacturing industry. Originating from the FDA’s 1990s ALCOA guidelines, it evolved into ALCOA+ in the 2010s to…