DeltaV™ Process Specification Management

Single source of truth for process specification information.

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Digitalize Your Recipe Development Process

DeltaV Process Specification Management (PSM) creates a continuum of process knowledge through the entire drug development lifecycle, from early-stage research through late-state commercial manufacturing, and provides a structured repository and collaboration model for recipes that facilitate drug development. DeltaV PSM enables global sites, cross-functional teams, and contract manufacturing organizations (CMO) to work together to scale recipes and execute technology transfers.

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Features

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, PKM conducts facility fit scenarios and easily identifies gaps through exception reporting.

One-Click Creation of Compliance Documents

Effortlessly generate documents in Microsoft Word format, eliminating manual review cycles.

Featured Technologies

DeltaV Process Risk Assessment

DeltaV Process Risk Assessment makes managing and scaling your risk assessment activities easier by using existing recipes built in DeltaV PSM. Users can effortlessly create different types of quantitative studies such as Cause and Effect and Failure Mode and Effect Analysis (FMEA).

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DeltaV Recipe Transfer Management

DeltaV Recipe Transfer Management reduces the tech transfer process to almost one click by digitizing the associated components, including recipes, workflows, scaling instructions, and process knowledge.

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