Managing GxP Environmental Systems To Ensure Data Integrity

By Piritta Maunu, Vaisala

In this paper, we provide some history of data management for life science systems and an overview of new regulatory expectations, including changes to guidance. We then offer eight recommendations for establishing and maintaining good practices for data integrity.

More than Bytes and Signatures

As efforts to ensure the quality and safety of drugs increase, so does the amount of data generated by those efforts. As a result, global regulatory scrutiny over the last few years has turned to providing guidance on preserving data quality. Throughout the life science industries — pharmaceutical research, manufacturing, medical devices and biotechnology — guidance and regulatory enforcement strategies are being re-evaluated with a focus on data integrity.