FDA 21 CFR Part 11 Requirements for NIR Spectroscopy

Traceability and accountability during pharmaceutical production is crucial to ensure adherence to pharma regulations and guidelines. In the past, the use of paper has been favored over electronic records and signatures, however, electronic systems may be more beneficial than previously thought. Advantages of electronic records compared to paper-based records are cost savings due to a reduced need for personnel to manage and maintain the files, an increase in data security, and improved accuracy. In this white paper, Metrohm demonstrates the use of NIRS software system for electronic record keeping.