DeltaV Process Specification Management

DeltaV™ Process Risk Assessment

Simplify evaluation of critical process parameters during drug development and production.

Seamless Integration for Easier Risk Assessments

DeltaV PSM allows users to identify CPPs and CQAs within manufacturing specifications. Since DeltaV PRA has full access to existing recipes built in DeltaV PSM, there is no need to manually re-enter critical process information as occurs with other risk assessment solutions, saving considerable time and effort and preventing errors.

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Click to continue reading Seamless Integration for Easier Risk Assessments
Seamless Integration for Easier Risk Assessments

Risk Studies

DeltaV PRA enables users to effortlessly create different types of quantitative studies. These include:

Cause and Effect
Cause and Effect (C&E)

Help correlate CPPs and CQAs by ranking the impact of CPPs on CQAs

Failure Mode Effect Analysis
Failure Mode Effect Analysis (FMEA)

Identify the potential ways a process might fail and evaluate the impact of each failure mode

Parameter Study
Parameter Study

Combine and summarize information across multiple studies in a single table

Functional Relationship Table
Functional Relationship Table

Display the relationship between parameters across multiple C&E studies

Key Features

Centralized Management of Critical Parameters

DeltaV PRA provides centralized management of CPPs and CQAs to create a single source of reference for risk assessments.

Centralized Management of Critical Parameters

Improved Change Control

Embedded change control functionality enables DeltaV PRA to maintain the integrity of the study and simplify GxP compliance.

Improved Change Control

Easy Access to Relevant Data

Information included in the risk studies can be easily filtered based on the step, activity and parameters.

Easy Access to Relevant Data

Enhanced Risk Understanding

Color-coded risk levels (based on predefined thresholds) improve visualization and understanding, supporting faster and better decision-making.

Enhanced Risk Understanding
DeltaV Process Specification Management
Digitize the Recipe Development Process

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.

DeltaV Process Specification Management (PSM)

PSM supports drug development from research to manufacturing, offering structured repository and collaboration for recipe management, enabling global teams and CMOs to scale and transfer technology efficiently.

DeltaV Process Specification Management
DeltaV Recipe Transfer Management

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

Digitize the Recipe Development Process

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