FDA 21 CFR Part 11 Requirements for NIR Spectroscopy
24 Apr 2018Traceability 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.
Related products
Request Quote for All Products
NIRS DS2500 Analyzer
Metrohm AGWith the compact NIRS DS2500, near-infrared analysis has taken yet another step into the future of routine analysis. This dedicated analyzer offers exceptional accuracy across a broad wavelength range of 400 to 2500 nm and is designed for routine analysis along the entire production chain. The predispersive Monochromator technology now being utilized in the NIRS DS2500 guarantees a high degree of versatility and stability across the entire spectral range from 400 to 2500 nm. With the maximum possible signal-noise ratio, the NIRS DS2500 simply performs, in less than one minute, analyses of both sophisticated and low-level parameters that must be very accurate. The NIRS DS2500 was created as a high-performance instrument for harsh production environments. Robust, easy-to-use and IP65 certified, it withstands humidity, dust, vibrations and temperature fluctuations. NIRS DS2500 Analyzer Features: Compact analyzer for reflectance measurements Maximum optical performance across the entire wavelength range (400 - 2500 nm) Matching results, even in difficult environments Network-capable via LAN (local) or direct PC connection New predispersive Monochromator Optional sampling accessories