Streamline Drug Development and Technology Transfers with a Digitalized Recipe Management System
Part of the DeltaV Process Knowledge Management suite of software, DeltaV Process Specification Management (PSM) provides a structured repository, flexible specification model, and collaboration environment for drug recipe development. By digitalizing the recipe development process and creating a continuum of product and process knowledge throughout the entire drug development lifecycle, the time required to translate recipes, perform technology transfers, and manage process parameter changes are significantly reduced.
Benefits of DeltaV Process Specification Management
Standardized Process Specifications
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.
Seamless Integration for Faster Technology Transfer
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.
Simplified Process Parameter Management
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.
Collaboration Across Functional Teams
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.
Now, Take Advantage of DeltaV PSM
Streamline your process management with intuitive tools, real-time analytics, and automated compliance solutions tailored for seamless operations.
Intuitive User Interface to Visualize Process Flows
Drag-and-drop user interface that simplifies and standardizes the creation of products and processes in conformance to ISA-88.
Parameter Calculation Engine
Structured, configuration-driven approach to efficiently manage process parameters and calculations without the need for tools such as Microsoft Excel.
Real-Time Facility Fit
Using predictive algorithms, DeltaV PSM conducts facility fit scenarios and easily identifies gaps through exception reporting.
One-Click Creation of Compliance Documents
Effortlessly generate reports and compliance documents, eliminating manual review cycles.
Side by Side Comparison
Quick identification of differences among different recipe versions, site variations, and libraries used.
Easy Connectivity
Integration framework to other systems via commonly used data exchange formats.
Explore Complementary Solutions
The DeltaV Process Knowledge Management software suite includes solutions for simplified risk assessment and technology transfer. These leverage the standardized process specifications and seamless integration capabilities provided by DeltaV PSM.
Featured Videos
Accelerating Tech Transfers
Learn how a common platform for information exchange can accelerate tech transfers by digitizing the drug development process, including recipes, workflows, and scaling instructions.
Accelerating Tech Transfers
Recipe Management in a Digital Plant
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