Impact Of Data Integrit on Pharmaceutical Industry ALCOA, ALCOA+, ALCOA++
Year: 2025
Type: article
Abstract: As well as being crucial for compliance reasons, ALCOA+ principles are becoming increasingly important to GMP (Good Manufacturing Practices). Their relevance is also growing as manufacturers in the life sciences sector continue to implement Industry solutions and processes. changed, duplicated, or moved. In terms of data integrity, data refers to all original records, including source data and metadata, whether they are kept on paper or electronically. ALCOA was suggested by various regulatory organisations, including the USFDA, Health Canada, and EMEA, to ensure the integrity of the data Attributable, Legible, Contemporaneous, Original and Accurate.
Author: Abhishek Pawar*, Abhishek Shrivastava, Dr. Jitendra Banweer
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6930853067
FWCI:
Cites:
Cited by:
Related to:
