ALCOA, API (Active Pharmaceutical Ingredient), audit trails, data integrity, warning letter, 21 CFR, CGMP (Current Good Manufacturing Practice), TQM (Total Quality Management)
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Data Integrity in the Pharmaceutical Industry
Abstract: Data should have consistency, completeness, accuracy which is the main requirement of data integrity. Safety of data is abeyance of—GDPR (General Data Protection Regulation) compliance – and security should be followed to regulatory compliance then such data become data integrity. It is maintained by a collection of processes, rules, and standards implemented till the finish product/drugs. Presently, the most discussed topic in the pharmaceutical/healthcare industry is the Data Integrity. Pharmaceutical …
Published in NOLEGEIN Journal of Management Information Systems · Vol. 3, Issue 2, 2021 · pp. 14–23 Read article