DeltaV™ Process Specification Management (PSM)

DeltaV PSM standardizes the product definition, specification structures, and process terminology through the research and clinical phases before the recipe is sent to execution systems such as manufacturing execution system (MES) or distributed control system (DCS). Using a configurable library of building blocks, PD/MSAT scientists can easily build and scale up processes digitally. Digitalizing process specifications (steps, activities, equipment, materials, etc.) that may currently reside in multiple Word documents, Excel spreadsheets, and other formats removes the laborious manual and error-prone task of managing data from these disparate sources.

DeltaV PSM offers enterprise-grade security, scalability, and the ability to integrate with other systems such as enterprise resource planning (ERP), electronic lab notebooks (ELN), and laboratory information management systems (LIMS). Seamless integration helps to standardize the process model across the drug development and manufacturing lifecycle and simplifies technology transfer, in some cases making it almost a one-click process.

The thousands of process parameters added and scaled during the recipe development process can be transferred easily and quickly to production systems, such as the manufacturing execution system or distributed control system, with minimal manual tasks. Having a single source of truth for recipe development helps improve change control. Alterations to the general recipe can be passed to site recipes with ease, requiring minimal manual tasks and providing full traceability.

DeltaV PSM facilitates collaboration across internal teams and contract development and manufacturing organizations (CDMO) on recipe development and technology transfers. Cross-functional teams can simultaneously access recipes, tag comments, attach documents, check-in/check-out unit operations, and utilize built-in workflows to manage approvals. DeltaV PSM offers sophisticated functionality including version control, change management, approval workflows and report generation that facilitates improved collaboration and cGMP compliance.