MicroLab FTIR software complies with 21 CFR Part 11 requirements with features such as user authentication, data security, electronic signatures, audit trail and system performance validation, to help users comply with 21 CFR Part 11 regulations
Agilent MicroLab FTIR Software is designed to meet the requirements of 21 CFR Part 11 for electronic data submitted to the FDA. The software provides features such as login security, data security, electronic signatures, and audit trails to ensure the validity and integrity of data, matching the effectiveness of signed paper records.
The manual details specific security functions including user-level permissions, data protection against unauthorized modification, and the generation of electronic signatures for methods and data files. It also explains the system logs and audit trails that track all changes to data, methods, and system checks, ensuring full traceability and compliance. This manual is written in Japanese.
Access is controlled by a username and password, which restricts execution and data access to authorized users only.
A warning is issued to the user if evidence of alteration is detected.
An expiration mark is placed on the signature if the data is reprocessed or modified after the signature is applied.