Refractometer and Polarimeter Software Facilitates FDA Reg.21 CFR Pt 11 Reporting

摘要

Computer systems,including analytical instruments with on-board processors that store or produce data to make quality control decisions,or reporting data for the FDA must comply with 21 CFR 11.This includes any laboratory results used to determine quality,safety,strength,efficacy,or purity.Because FDA reg.21 CFR part 11 states that closed computer systems must have a collection of technological and procedural controls to protect data within the system,Xylem brand Bellingham + Stanley refined a selection of its instruments to help customers easily comply,including the ADP450 and ADP600 Series of polarimeters as well as the RFM900 Series refractometers.