Integration of Digital Validation Platforms with Real-Time Reporting Tools to Enhance cGMP Compliance in Pharmaceutical Manufacturing
Keywords:
digital validation, real-time reporting, cGMP compliance, pharmaceutical manufacturingAbstract
Combination of digital validation platforms with real time reporting tools represents a transformative approach which can enhance compliance with current good manufacturing practises (cGMP) in pharmaceutical manufacturing. The objective of this paper is to explore the universe application of digital validation systems such as KneatGx Besides its advanced analytic platforms which includes Qlik Sense and IBM Cognos establish an automated data driven compliance framework.
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References
U.S. Food and Drug Administration, “Title 21 CFR Part 11 – Electronic Records; Electronic Signatures,” Code of Federal Regulations, 1997.
European Medicines Agency (EMA), “EU GMP Annex 11: Computerised Systems,” EudraLex Volume 4, 2011.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), “ICH Q9: Quality Risk Management,” ICH Guidelines, 2005.
GAMP 5 Steering Committee, “Good Automated Manufacturing Practice (GAMP 5): A Risk-Based Approach to Compliant GxP Computerized Systems,” International Society for Pharmaceutical Engineering (ISPE), 2017.
M. Boehm et al., “Ensuring Data Integrity in cGMP Compliance: Digital Validation Approaches,” Journal of Pharmaceutical Sciences, vol. 109, no. 4, pp. 1021–1035, 2021.
A. Patel and R. Desai, “Automating Pharmaceutical Validation: The Role of Digital Platforms,” International Journal of Pharmaceutical Sciences and Research, vol. 12, no. 3, pp. 240–255, 2022.
T. Smith and P. Jones, “Blockchain for Regulatory Compliance in Pharma Manufacturing,” IEEE Transactions on Engineering Management, vol. 69, no. 5, pp. 1500–1512, 2021.
Kneat Solutions, “KneatGx: Digital Validation and Compliance Solutions,” White Paper, 2022.
M. Richards, “Real-Time Data Analytics for Compliance in Pharmaceutical Manufacturing,” Pharmaceutical Engineering Journal, vol. 42, no. 7, pp. 89–104, 2022.
J. Zhao et al., “AI and Machine Learning for Regulatory Compliance Monitoring in cGMP Environments,” Artificial Intelligence in Medicine, vol. 118, no. 12, pp. 45–63, 2021.
D. Thompson, “The Future of Digital Validation in the Biopharmaceutical Industry,” Journal of Validation Technology, vol. 29, no. 1, pp. 32–49, 2023.
IBM, “IBM Cognos Analytics: Enhancing Pharmaceutical Data Intelligence,” White Paper, 2023.
Qlik Technologies Inc., “Qlik Sense for Pharmaceutical Compliance and Reporting,” Technical Report, 2023.
M. Becker et al., “A Risk-Based Approach to Computer System Validation in Pharmaceutical Manufacturing,” Computers in Industry, vol. 134, pp. 103–120, 2023.
World Health Organization (WHO), “WHO Good Manufacturing Practices for Pharmaceutical Products,” Technical Report Series, no. 986, 2016.
R. Kumar and S. Banerjee, “Cybersecurity Challenges in Digital Validation and Compliance Systems,” IEEE Transactions on Information Forensics and Security, vol. 18, no. 6, pp. 892–908, 2022.
H. Martin and C. Lewis, “Advances in Cloud-Based Validation for Pharmaceutical Manufacturing,” Journal of Cloud Computing and Regulatory Compliance, vol. 10, no. 2, pp. 67–84, 2022.
Fresenius Kabi USA, “Digital Transformation in Pharmaceutical Validation: Case Study,” Internal Report, 2021.
E. Schmidt et al., “Leveraging AI and IoT for Predictive Compliance Monitoring in Pharmaceutical Manufacturing,” IEEE Internet of Things Journal, vol. 10, no. 3, pp. 354–371, 2023.
A. Roberts, “Regulatory and Technological Perspectives on AI-Based cGMP Compliance,” Nature Reviews Drug Discovery, vol. 20, no. 8, pp. 519–534, 2022.