Data Integrity in the Pharmaceutical Industry
The reliability and integrity of pharmaceutical data is fundamental for regulatory compliance and consumer safety. Preserving data integrity, from initial gathering through traceable data transfer to safe storage in pharmaceutical manufacturing, is essential. Although, manual record keeping and transcription is a common way of documenting data, it is also one of the major sources of error and other data integrity violations.
In the latest of a series of experts talks from the Pharma Quality Exchange, Christoph Jansen, a GMP expert talks to Ian Scott-Mance about the latest data integrity regulations from the Food and Drug Administration (FDA) and the focus on moving to electronic data. Listen to the conversation on how electronic data gathering solutions can help to make sure documentation is complete, accurate and traceable.
With consumer safety a key driver for improving data integrity, Christoph shares his knowledge of the five principles of data integrity (ALCOA), the common misconceptions surrounding CFR 21 Part 11 and the ways to enforce behaviour with digital technical controls.