What is a “risk-based approach” to 21 CFR 11 compliance?

FAQs Standards

An example of a risk-based approach would be considering the use of a word processor used to record cleanroom results. The most likely sources of error would come from transcribing results and the porting of data from a print-out to a secure database. In such a situation, compliance activities would include ensuring the word processor had secure access, the SOP for inputting data was comprehensive and compliance was routinely spot-checked.