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. 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. This paper gives an overview of Data management solution to simplify regulatory compliance if such storage mediums are electronic.
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