Process Development for the 21st Century
Scientists have always been driven by the search for knowledge and understanding. Integral to process development is the analysis and application of that knowledge to produce a safe, rugged, well-controlled process that consistently yields a high quality product. In the past, these efforts were constrained by resources (time and manpower). As a result, processes were designed to be run within a narrow range of operating limits. Filing amendments were required for process changes.
Today, we have no additional resources, but the productivity of those resources can be significantly greater. Electronic laboratory notebooks capture the details of experiments. Laboratory automation has made the acquisition of large amounts of data feasible. Modeling tools allow the prediction of process behavior under conditions outside experimental constraints. Software tools make the analysis of data and management of knowledge easier. This additional data and increased level of understanding allows a process to be defined within a broad range of operating conditions and dynamically adjusted to compensate for variations. This approach is key to the regulatory relief afforded by applying Quality by Design. Increases in productivity can be applied to the Quality by Design approach or to supporting additional projects.
Introducing these tools to your organization is not a simple matter of installing hardware and software. In addition to configuration and integration with existing systems, successful implementation of this technology requires major cultural changes with stakeholders at all levels and many parts of your organization.
If you need assistance in organizing your productivity project, please contact Development21.