ABSTRACT
Procedures for compliance with 21 CFR Part 11 – must adhere to data integrity compliance, e.g., all lab instruments, process control systems (PLC or HMI), computerized systems, and excel spreadsheets used should all comply with data collection, storage, and usage requirements such as:
PLC (programmable logic controllers) or other intelligent processors
HMI (human machine interface)
Analytical instrument software
Computer systems
Data Integrity – This is the extent to which all data are complete, consistent, and accurate throughout the data lifecycle. Complete, consistent, and accurate data should be attributable, legible and permanent, contemporaneously recorded, original or a true copy, and accurate (ALCOA).
