A Machine Learning-Based Framework for Risk-Based Validation of Computer Systems Under 21 CFR Part 11 Compliance
Keywords:
machine learning, risk-based validation, computer system validation, 21 CFR Part 11Abstract
Computer systems under 21 CFR Part 11 compliance based on machine learning framework for risk-based validation presents a unique approach to optimise regulatory validation processes in pharmaceutical and life science industries. Utilising both supervised and unsupervised learning algorithms this framework will equally assess risk factor associated with computerised systems Also privatises validation efforts based on predictive risk analytics. Through the help of this methodology time and resource require can be significantly reduced and at the same time enhances compliance through automated and data-driven decision making.
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References
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