Ensuring data integrity: Best practices and strategies in pharmaceutical industry
Year: 2024
Type: article
Abstract: 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. 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. 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. 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.
Source: Intelligent Pharmacy
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,200
OpenAlex ID: W4402898494