WP-018
FDA 21 CFR Part 11 Requirements for NIR Spectroscopy
Tóm tắt
This Metrohm White Paper shows the requirements demanded of the pharmaceutical industry by the FDA with respect to software products. Implementation examples of the regulations formulated by the FDA in 21 CFR Part 11 are presented using Vision Air Pharma Software.
Key words: electronic signatures, audit trails, user management, documentation