Glossary
ALCOA+
What is ALCOA+ ?
ALCOA+ expands on the ALCOA principle by adding attributes like Complete, Consistent and Enduring. This principle further focuses on improving data reliability, traceability and compliance in regulated industries like biopharma, pharmaceutical, food & beverages, cosmetics and other industries.
What does ALCOA+ stand for?
ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent and Enduring.
What is the Importance of ALCOA+ in pharma?
ALCOA+ adds upon the ALCOA principles to ensure further data integrity and compliance in pharmaceutical industry. It proposes that the pharma sector maintain high standards in data quality throughout all stages of drug development, manufacturing and distribution. This ensures heightened regulatory compliance, product quality and safety. ALCOA+ helps companies in upholding transparency, traceability, and accountability in data management practices.
How is ALCOA+ implemented in pharma?
ALCOA+ principles are implemented in the pharma industry through good documentation practices in manufacturing and quality control. This can be done with an adept document management system that can conduct regular internal audits with proper training of employees on documentation practices.
