Ursula Tems
Articles
Enhancing Confidence in Compliance
June 13, 2016
This note highlights OpenLAB ECM Compliance Pack for UV-Vis Benefits such as efficient data storage and retrieval, security, data integrity and traceability, and 21 CFR Part II Comliance.
GOOD LABORATORY PRACTICE Agilent Cary 8454 UV-Visible Spectroscopy System
June 13, 2016
This note looks at specific components that require validation; the instrument, software, and validated test methods, and describes the features of the Agilent Cary 8454 UV-Visible system that is designed to meet the requirements of both initial and recurrent validation.
QA/QC PHARMACEUTICAL SOLUTIONS - Cary 8454 UV-Visible Spectroscopy System
June 13, 2016
This note describes how the design of the Cary 8454 UV-Vis exceeds performance requirements stipulated by global pharmacopeia guidelines including USP and EP/BP. Configured for compliance, with 21 CFR Part 11, the instrument performs multi wavelength analysis, time-based kinetics assays, and routine QA/QC measurements.