Patil Divyashree Kantilal
Amruta.N.Patil
Mansi Dhankani
Sunil.P.Pawar
- Research Scholar P.S.G.V.P. Mandal’s College of Pharmacy Shahada Maharashtra India
- Assistant Professor P.S.G.V.P. Mandal’s College of Pharmacy Shahada Maharashtra India
- Assistant Professor P.S.G.V.P. Mandal’s College of Pharmacy Shahada Maharashtra India
- Principal P.S.G.V.P. Mandal’s Collage of pharmacy Maharashtra India
Abstract
Data integrity stands as a linchpin in the reliability and trustworthiness of systems involved in handling, analyzing, and retrieving information, safeguarding the accuracy and consistency of data from inception to disposal. This paper delves into the multifaceted realm of data integrity, encompassing its definition, pivotal importance, regulatory underpinnings, core principles, and practical implementation strategies. A comprehensive exploration of regulatory guidelines, including ICH Q7, EU Annexure 11, and FDA regulations, underscores the paramount significance of data security and adherence to good documentation practices. Emphasis is placed on the pivotal role of corporate culture, risk assessment, and data governance in fortifying data integrity, bolstered by enlightening case studies illustrating instances of data integrity lapses. Key principles, encapsulated by the acronym ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available), are meticulously examined to provide a foundational understanding for maintaining data integrity. The paper culminates with insights into pivotal aspects such as data review, audit trails, data security measures, cultural influences, and an analysis of contemporary trends in FDA warning letters associated with data integrity breaches. Recognizing and implementing robust data integrity practices are posited as imperative for organizations, serving as a linchpin for ensuring product quality, upholding regulatory compliance, and fostering public trust. In a rapidly evolving landscape, staying abreast of current trends and challenges in data integrity is essential for organizations navigating the intricate terrain of the pharmaceutical industry.
Keywords: Data integrity, Regulatory compliance, Data governance, Risk assessment, ALCOA+.
[This article belongs to Research & Reviews: A Journal of Pharmaceutical Science(rrjops)]
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References
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Research & Reviews: A Journal of Pharmaceutical Science
| Volume | 15 |
| Issue | 01 |
| Received | March 7, 2024 |
| Accepted | March 26, 2024 |
| Published | March 30, 2024 |