Increased capacity, fewer errors, no more paperwork. These were some of the key points to take away from the presentation by John Helfrich of VelQuest Corporation called “CGMP Informatics: IT Infrastructure Design for 21st Century Pharmaceutical QC Operations” at INTERPHEX. The session reviewed a compliance-management system that can be integrated with existing systems to streamline QA/QC lab processes. An electronic notebook system (ELN), in this case, VelQuest’s “SmartLab” system, can work with an existing laboratory information management system, or can be implemented into an environment without one. In the lab, the system is validated so fewer checks are required of reviewers, also, the process is validated before testing begins.
The ELN can automate processes and make the job easier for a QA/QC department. The software can be customized to fit the procedures of a specific lab, including giving different users different levels of permission as in the case of a senior analyst having access to more functions than a junior analyst. Laboratory instruments can be registered in the system, which can provide information on each one used. For example, the system can warn users when an instrument is due to be calibrated. Calculations, data capture, and report generation can also be automated. Companies using the technology have reported increased productivity due to the time saved and the reduction of errors when using an ELN system. Paperwork is reduced, or eliminated, because data is entered and managed directly on wireless tablet PCs or wired workstations.