This article introduces the integrity verification of electronic records in 21 CFR Part 11, including electronic signatures, electronic records overview, security, data integrity, monitoring records, electronic watchdogs, etc.
This document is the third part of a technical series by Agilent Technologies and Yokogawa Analytical Systems regarding compliance with 21 CFR Part 11. It focuses on ensuring data integrity in analytical laboratories, specifically addressing how to protect raw data from accidental or intentional alteration.
The text details the requirements for audit trails (electronic guardrails) that record who created, modified, or deleted electronic records and when these actions occurred. It discusses the necessity of capturing metadata and change history for re-analysis. The document also covers FDA guidelines on time stamps, emphasizing the need to clearly document the sequence of events and authenticate signatures to prevent repudiation. This manual is written in Japanese.
It must record who performed the action, when it occurred, and what was changed, ensuring records are secure and computer-generated.
The signer's local time must be recorded to clearly document the sequence of events, though this can vary based on network system configurations.