Before the advent of integrated computer systems, LIMs, HMI interfaces, comprehensive software, CGMP, BAS, process control systems, PAT, and the use of statistics, manual record keeping was fraught with errors—most of them unintentional. This led to citations for missing data, signatures, and date and time entries, to say nothing of the risks posed to patient safety.
Since the Sarbanes-Oxley Act was passed by the US Congress in 2002, a greater emphasis has been placed on data integrity in biopharmaceutical manufacturing. Changes in 21 CFR part 11, ICH mandates, and European and US pharmacopoeias have also influenced the need to maintain data in formats that are both sacrosanct and inviolate.
Today, the need for data integrity is foremost in our documentation, analytical records, measurements, and requirements. Data integrity demonstrates that processes operate within proscribed limits, and ensures that we can archive, retrieve, and show the data for any state of the process at any given moment in time.
This Special Report provides insights into how we manage, use, and incorporate data to protect the integrity of all values, measurements, and processes—as well as comply with regulatory mandates and guidances.
