About this document

Data Integrity in Biopharma 4.0 by Let it be is a document available to read on EtoBox.

This mini-review discusses the critical importance of data integrity (DI) in the biopharmaceutical sector, particularly as it transitions towards Industry 4.0, which involves advanced automation and data analytics. It identifies common DI risks and violations, linking them to regulatory standards such as ALCOA+ and highlights the need for robust computerized systems to ensure compliance and maintain product quality. The paper also emphasizes the role of validated systems and training in mitigating DI risks

Author

Let it be

Language

EN