Why is SmartLab referred to as a “GMP Electronic Notebook System” instead of just an ELN (electronic lab notebook)?
SmartLab is a “purpose-built” method or lab execution system for cGMP operations. It is not a general purpose, open ended, free form ELN for general purpose R&D-like use. The cGMP lab environment is VelQuest’s only focus and, as such, the SmartLab GMP Electronic Notebook System contains all the specific GMP related details for compliant data capture and documentation requirements. SmartLab provides a systematic and disciplined approach to ensure that only the latest approved methods are available to analysts that are trained on the method – it ensures that only calibrated instruments are used in the process and that all supplies are in date. In addition, procedure data thresholds for each step in the process allows the “system” to flag any data element that falls outside of the expected normal range thus establishing a “right first time” process for the QC lab.
