Achieving Data Integrity in the Life Sciences Industry

Data management designed to simplify regulatory compliance and enhance trust

Rapid world growth, globalization, advanced technologies for Pharma 4.0 automation and data analysis trends, are emphasizing the need for high standards of data quality and integrity. Good data practices (GxP) will enrich the quality of data, enabling life science companies to make strategic decisions on batch release, based on trustable data and analytical insights.

The pharmaceutical and biotechnology industries closely regulate data production and storage to make sure that data cannot be modified without detection. Regulatory bodies such as the FDA and EMA, as well as global institutions and associations like the WHO, ISPE, PIC/S and local CDSCO, NMPA, MHRA, ANVISA, etc, emphasize the need for accurate measurement and secure storage of critical process and environmental parameters. If such storage mediums are electronic, then the methods used for controlling and monitoring of data should comply with regulations, for example FDA 21 CFR Part 11, to help ensure data integrity.