Intelligent Pharmacy · Published 2024-09-26 · DOI 10.1016/j.ipha.2024.09.010
Background: The objective of this article is to examine the challenges and best strategies for incorporating data integrity in the pharmaceutical industry to ensure regulatory compliance. It highlights the importance of data governance policies, secure data handling processes, and the use of the ALCOA framework for implementing Good Documentation Practices. Evidence acquisition: Using appropriate search terms such as 'Data Integrity', 'Data Integrity in Pharmaceutical Industry', and 'ALCOA principle', evidence was gathered from websites and published articles using SciFinder, Web of Science, PubMed, UGC-approved journals, and Google Scholar databases. Results: The article emphasizes the importance of change management, independent data review methods, and modern technology such as electronic signatures and audit trails in pharmaceutical companies. It also points out the importance of data backup, recovery procedures, and ongoing improvement in maintaining data integrity and promoting responsibility. Conclusion: The article discusses the pharmaceutical sector's procedures for ensuring data integrity throughout a product's life, promoting safe, efficient, and excellent pharmaceutical goods. It highlights the need to navigate the complex regulatory environment and emphasizes the sector's commitment to maintaining data integrity to achieve high quality standards in manufacturing and testing operations.
Abstract from DOAJ. Public domain (CC0 1.0).
Read the article at the publisher →