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Change Impact Assessment

Simplify change, reduce errors, and move faster with confidence.

Simplify change management and accelerate development across your product lifecycle.

Managing change in regulated product development is complex. Even small updates can ripple across requirements, tests, risks, and documentation, making manual Change Impact Assessment slow, inconsistent, and difficult to scale.

Ketryx replaces document-by-document DHF reviews with AI-assisted, traceability-driven workflows that help teams quickly understand impact, take action, and stay compliant as products evolve.

Change Impact Assessment

Managing changes in regulated product development is complex.

A small change, adding, removing, or modifying a component, can cascade across requirements, tests, risks, and documentation. Teams often spend days manually tracing these dependencies across fragmented tools just to understand scope, delaying development and increasing the risk of missed downstream impacts.

Ketryx helps teams manage change with AI-powered impact scoping, analysis, and deterministic flagging, so teams can move from proposed change to completed change impact assessment with confidence.

How a Medical Diagnostics Leader Reduced Change Impact Assessment from Days to Hours with Ketryx AI

An innovative AI-driven diagnostics company uses Ketryx’s AI-native compliance platform to generate hardware and software change impact assessments in hours, a task that took up to 15 FTE days per change previously. Using Ketryx resulted in a 70% reduction in documentation drafting time and review effort for hardware and software changes.

Read the case study

Enable your teams to implement changes quickly and confidently, even in complex, regulated environments.

Ketryx supports Change Impact Assessment through a clear, end-to-end workflow:

  1. Analyze scope and dependencies
  2. Take action to apply changes
  3. Flag potential downstream impacts
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Analyze Changes in Minutes

Quickly analyze proposed changes and understand their scope across the DHF. The Ketryx Assistant helps teams identify up to 80% of impacted areas in minutes, replacing manual review with AI-powered analysis.

Explore how Ketryx can streamline analysis
Identifies impacted requirements, tests, and documentation across the DHF
Surfaces upstream causes and downstream consequences to align teams on scope
Reduces initial impact analysis from days to minutes with traceable, audit-ready insights

Turn Analysis into Action

The agent guides teams through change impact assessment workflows with concrete, traceable recommendations, reducing manual effort by up to 70% and completing assessments in hours instead of weeks.

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Learn more about Change Impact Assessment Agent
Guides teams through structured, consistent change impact assessment workflows
Translates identified impacts into clear actions addressing risks, dependencies, and compliance
Maintains full traceability from change to decision with approval, refinement, or rejection in-platform

Flag Affected Design Controls

Ketryx proactively flags downstream design controls affected by changes, giving teams early visibility before change impact assessment work begins. This lightweight awareness step helps teams avoid missed dependencies and start impact analysis with context.

Explore change impacts
Adds visual flags to impacted DHF items including requirements, tests, risks, and documentation
Provides early awareness without forcing action or sending notifications
Reduces overlooked changes before formal change impact assessment begins