Glossary
ALCOA
What is ALCOA?
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. It is an essential principle for documentation and data management in regulated industries. ALCOA guidelines emphasize on data integrity throughout process lifecycle for regulatory compliance, quality assurance and patient safety.
What is the importance of ALCOA in pharma industry?
ALCOA is a crucial guideline for ensuring data integrity and quality in pharma. It takes care that all data captured is attributable, legible, contemporaneous, original and accurate. Adherence to ALCOA is important for regulatory compliance, it upholds credibility of research, clinical trials, manufacturing processes and ultimately safety and efficacy of products.
What industries need to comply with ALCOA principles?
The Pharmaceutical, Biotechnology, Medical Devices, Food & Beverages, Cosmetics, Chemical industries, etc must comply with the ALCOA principles.