Use Case: Impact Analysis & Submission Readiness with a Regulatory Knowledge Graph

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Use Case: Impact Analysis & Submission Readiness with a Regulatory Knowledge Graph

Why This Use Case Matters

Critical Pain Point: Every design change or regulator query triggers weeks of manual cross‑checking across PLM, QMS, ERP, and spreadsheets.
Measurable Impact: Time and labor savings are concrete; regulators recognize faster, more complete responses.
Scalable Value: One successful pilot extends across operating companies, multiplying benefits.

The Vivid Scenario

Change Event: A design change order (ECO) is approved for a surgical device component.

Regulatory Questions:

Which global submissions reference this component?
Which requirements, risks, and tests are impacted?
Which evidence documents are missing or outdated?

Today (Manual)

80–120 hours/submission digging across systems.
Weeks of delays in responses.
High risk of findings during regulatory audits.

With a Graph

Single query returns all impacted submissions across markets.
Linked risks, requirements, and tests identified instantly.
Readiness score highlights missing or outdated evidence.
Evidence packet automatically assembled for regulator response.

Our Solution

Data Intelligence Capabilities Applied:

AI‑Enhanced Ingestion: Automated structuring of content from PLM/QMS/ERP documents (design files, lab reports, DHF/DMR, CAPA) using AI‑powered OCR and NLP.
Graph‑Powered Intelligence: Map relationships between product components, risks, requirements, tests, submissions, and evidence for real‑time impact analysis.
Generative AI + RAG Decision Support: Augment LLMs with graph/structured data to draft regulator responses, citing evidence directly from source systems.

Business Value (Example Calculation)

Baseline: 120 hours/submission for impact analysis & evidence gathering.
With Graph: ~24 hours/submission (80% reduction).

Assumptions:

Analyst cost = $90/hour
150 submissions/year per division
~20 global divisions

Formula: Savings/Subm = (Baseline Hours − With Graph Hours) × Hourly Cost

Savings:

96h saved × $90 = $8,640 per submission
$8,640 × 150 submissions = $1.3M saved annually per division
20 divisions × $1.3M = ~$26M annual global savings

Additional upside: every week faster = millions in incremental device revenue.

Key Metrics (Expected Impact)

~80% Reduction in effort per submission

~$26M Annual global labor savings

Higher Audit‑readiness & compliance

Key Message

Every regulator query currently consumes thousands of hours in manual evidence assembly. A Regulatory Knowledge Graph reduces weeks of work to minutes — unlocking $25M+ in annual savings, strengthening compliance, and accelerating approvals. Compliance shifts from a cost center to a source of competitive advantage.