Leverage Workflows through Automation
Inference for QbD enables organizations to integrate data resources, analytic capabilities and analytic protocols with structured, explanatory text into a single informatics framework as a QbD workflow. QbD workflows are delivered to scientists and engineers as QbD templates across geographically-distributed elements of the organization as well as across different functional lines. QbD templates are built from a combination of R core and R QbD functions. Workflow templates provide a quick way to re-use workflows that have already been created. The Inference for QbD Template Library is a useful collection of pre-built QbD templates that cover the principal elements of QbD workflow, for use out-of-the-box or modified to meet specific needs.
QbD templates can be applied to a range of QbD workflow situations from very simple to very complex. Illustrative examples are given below:
- Automated Data Analysis.Typically used when significant input is not required, the same computational protocol is used many times, experimental design and data structure is well defined, and there is a need to include explanatory notes with data-analysis results.
- Scheduled Reports. Typically used when static reports need to be updated on a regular basis. The report (e.g., stability study update report) integrates the data source, free text, computational results, and formatting.
- Specialized Desktop Applications. Typically involve parameterized computations, where the user provides parameters, data and metadata. An example is deployment of a process simulation model on which individual recipients can perform “what if” experiments within a context of their choosing.
- Pharma-Development Workflow Applications. These are the most complex templates that involve collaboration among multiple workers, functions and locations. Typically these are long-running and complex workflow process, which requires a centralized information repository and workflow management. Representative examples include analytical method validation as well as CMC filing and project management.