Understanding ALCOA(+) to Improve Data Integrity and Reduce Risk [Lecture Preview]

Watch Rick Jarrell detail the importance of data integrity and how to meet ALCOA(+) requirements from the Interphex Life Science and Pharmaceutical Expo.

Pharmaceutical/biotechnology manufacturing and engineering businesses have largely moved data collection to a practice of digitized record management. There is a large range of systems to choose from that can help businesses validate the quality of their products more efficiently, and comply to safety regulations, such as the FDA's 21 CFR Part 11, as well as guidelines offered by MHRA, WHO, and other organizations worldwide. However, data integrity remains one of the greatest challenges within the Life Science industry. Duplicate data, missing data, inaccurate data, or incorrect data all fall into the category of bad data. Thankfully, there is significant alignment and an international conversion on data and metadata integrity requirements. This conversion is summarized nicely with the FDAs guidance and the ALCOA+ guidelines. It is required that there be a significant understanding of the risks and remediation associated with the individual components of ALCOA+.

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