How AI and Paperless Systems Are Revolutionizing Quality and Compliance in Drug Manufacturing
DOI:
https://doi.org/10.63282/3050-922X.ICRCEDA25-142Keywords:
Artificial Intelligence, Digital Transformation, Document Management Systems, Good Manufacturing Practices, Laboratory Information Management Systems, Lifecycle Management, Manufacturing Execution Systems, Natural Language Processing, Paperless Validation, Pharmaceutical Compliance, Risk-Based Validation, Supervisory Control, Data AcquisitionAbstract
The health-care industry is undergoing a rapid transformation driven by the growing demand to meet regulatory standards along with improving operational efficiency. Current validation practices, involving heavy paper-based documentation practices and manual workflow, find it difficult to meet the requirements of modern manufacturing. This paper details how AI approaches to comply with pharmaceutical companies with GMP requirements using paperless validation systems. The use of AI for risk assessments, real-time system monitoring, and generating documents using NLP tools helps companies to significantly improve compliance, reduce operational costs, and accelerate product lifecycles
References
[1] ISPE. (2022). "GAMP 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems."
[2] McKinsey and Company. (2020). "Pharma 4.0: How digital transformation is reshaping the industry."
[3] FDA. (2022). "Computer Software Assurance for Production and Quality System Software."
[4] European Medicines Agency. (2014). "ICH Q9: Quality Risk Management."
[5] Deloitte. (2021). "AI in Life Sciences: Enhancing compliance through predictive analytics."
[6] FDA. (2011). "Process Validation: General Principles and Practices."
[7] IBM. (2020). "Natural Language Processing in Regulated Document Automation."
[8] Gartner. (2021). "Smart Manufacturing and Real-Time Compliance Monitoring."
[9] PwC. (2022). "Digital Validation in Pharma: Unlocking value with AI and automation."
[10] ISPE. (2022). "GAMP 5 Second Edition: Enabling Pharma 4.0."
[11] Kneat Solutions. Digital Validation Software in the Pharma Industry. White Paper, 2023.
[12] ValGenesis. Paperless Validation Lifecycle Solutions, 2023
