Advancing Data Integrity in FDA-Regulated Environments Using Automated Meta-Data Review Algorithms
Keywords:
data integrity, FDA compliance, metadata review, automated validationAbstract
FDA-regulated pharmaceutical regulatory compliance environment’s continuously increasing complexity demands advanced methodologies for ensuring data integrity. The purpose of this research paper is to dive deep into the automated algorithmic framework for Meta-Data Review Assessments (MRA) which leverages machine learning algorithms and digital validation platforms such as KneatGx to systematically address compliance with 21 CFR Part 11 and cGxP requirements.
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