Mr. Atul. Y. Nagre, Dr. Gadapuram Tharunkumar, Mr. Arshad A. Ansari , Ms. Pooja Ambhure, Mr. Avinash G. Wagh, Dr.Sunil . S Jaybhaye
Institute of Pharmacy Badnapur, Maharashtra
Abstract
This comprehensive review article delves into the intricate realms of pharmaceutical regulations, focusing on the synergy between 21 CFR Part 11 and Part 26. It begins by unraveling the essentials of 21 CFR Part 11, meticulously exploring electronic record controls, audit trails, electronic signatures, and their pivotal role in preserving data integrity. The narrative unfolds with insights into compliance challenges and innovative solutions, offering a roadmap for organizations to navigate the dynamic landscape of regulatory adherence. The review extends its gaze to the profound impact of 21 CFR Part 11 on data integrity, emphasizing its role as a guardian of authenticity and reliability in the pharmaceutical industry. Validation and verification processes emerge as crucial gatekeepers, ensuring the seamless performance of electronic systems and bolstering the security of electronic signatures. Real-world case studies enrich the narrative, providing tangible examples of organizations overcoming stage, illuminating how the fusion of electronic recordkeeping with global good manufacturing practices fosters a unified approach to compliance excellence. The exploration concludes with an examination of recent updates and future trends. From the continued emphasis on cybersecurity to the integration of blockchain technology and the evolution of remote auditing practices, the pharmaceutical industry is poised at the forefront of technological innovations that will redefine compliance standards. In essence, this review article serves as a comprehensive guide for pharmaceutical stakeholders, offering insights, solutions, and strategic perspectives to navigate the evolving landscape of compliance and ensure the highest standards of data integrity, patient safety, and regulatory excellence.
Keywords: 21cfr, Guidelines, Part 11, Part 26
Journal Name :
EPRA International Journal of Research & Development (IJRD)

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Published on : 2025-06-14

Vol : 10
Issue : 6
Month : June
Year : 2025
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