See how one change ripples through your entire GxP system

Model regulated manufacturing workflows, simulate a process change, and instantly trace cascading impacts across SOPs, training records, validation protocols, and regulatory submissions — with AI-powered regulatory analysis.

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How it works

Model your regulated workflow, classify a change by FDA category, and watch the consequences propagate in real time.

Build

Model your manufacturing workflow

Drag and connect GxP document types — process steps, SOPs, training records, batch records, equipment qualifications, validation protocols, specifications, stability protocols, CAPAs, and regulatory submissions — to map your manufacturing dependencies.

Process Step

Cell Washing

SOP

SOP-0042

Training

TR: Operator A

Simulate

Trigger a process change

Select any process step and define a change — a temperature adjustment, a reagent substitution, a protocol modification. Then classify it as Minor, Moderate, or Major per FDA SUPAC guidelines. The category determines which regulatory filings are required.

Select a change to simulate on Cell Washing

Change washing temperature (4°C → 8°C)

Change centrifugation speed (300g → 400g)

Trace

See the cascading impact

Watch impacts propagate through your workflow in real time. Nodes keep their type colors — severity badges appear on each affected node so you can see what changed at a glance. Each impact includes AI-generated regulatory analysis with citations from 21 CFR 314.70, SUPAC, ICH Q12, and more.

SOP

SOP-0042: Cell Washing

high

Validation Protocol

VP-015: Process Validation

critical

Equipment Qual.

EQ-009: Centrifuge OQ

medium

In regulated manufacturing, no change exists in isolation

A single process parameter change can trigger SOP revisions, operator retraining, batch record updates, equipment re-qualification, process revalidation, and regulatory filing amendments. Cascade makes these hidden dependencies visible.

Document types

SOPs, batch records, training, validation, specs, stability, and more

Cascade rules

Category-aware severity mapping per FDA SUPAC guidelines

Change categories

Minor, Moderate, Major — each triggers different regulatory filings

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