KG Intelligence API Overview

The KG Intelligence API provides AI-powered regulatory intelligence for pharmaceutical and life sciences companies. Built on a curated Knowledge Graph, the API enables event classification, regulatory mapping, risk assessment, and trend analysis for FDA compliance.

What is the Knowledge Graph?

The OrchestraPrime Knowledge Graph is a structured, evidence-backed database of regulatory knowledge including:

• FDA 483 Observations: 15,000+ observations from 2020-2024
• CFR Regulations: Complete Title 21 CFR with cross-references
• ICH Guidelines: Q7 (API GMP), Q9 (Risk Management), Q10 (Quality System)
• Event Taxonomy: 50+ quality event types with regulatory mappings
• Citation Analytics: Frequency data, trends, and benchmarks

The Knowledge Graph uses semantic embeddings and entity resolution to connect events, regulations, guidelines, and historical observations into a unified intelligence layer.

Core Capabilities

1. Event Classification

Automatically classify quality events and map them to applicable CFR regulations.

Use Cases:

• Classify FDA 483 observations during inspections
• Map deviations to regulatory requirements
• Identify applicable regulations for CAPA investigations
• Standardize quality event categorization

Endpoint: POST /v1/intelligence/classify

Example:

curl -X POST "https://LAMBDA_URL/v1/intelligence/classify" \
  -H "Content-Type: application/json" \
  -d '{
    "event": "Equipment calibration records missing for temperature probe",
    "product_type": "drug"
  }'

Response Highlights:

• Event type classification with confidence score
• Applicable CFR sections (direct and indirect)
• Event category and default severity
• Full evidence provenance

2. Comprehensive Investigation

Perform deep investigation including classification, similar historical observations, ICH guideline mapping, and AI-powered risk assessment.

Use Cases:

• Investigate major deviations and out-of-specification events
• Research similar FDA 483 citations for precedent
• Identify relevant ICH guideline sections for compliance
• Generate data-driven risk assessments
• Support CAPA root cause analysis

Endpoint: POST /v1/intelligence/investigate

Example:

curl -X POST "https://LAMBDA_URL/v1/intelligence/investigate" \
  -H "Content-Type: application/json" \
  -d '{
    "event": "Cleaning validation study did not include worst-case scenarios",
    "product_type": "drug",
    "include_similar": true,
    "include_ich": true,
    "include_risk_assessment": true
  }'

Response Highlights:

• Event classification and applicable regulations
• Similar FDA 483 observations via semantic search
• Relevant ICH Q7/Q9/Q10 guideline sections
• AI-powered risk assessment with recommended actions
• Citation frequency and trending data
• Complete evidence chain

3. Regulatory Reference

Access complete CFR regulations and ICH guidelines with cross-references and citation analytics.

Use Cases:

• Reference CFR section details during procedure development
• Review ICH guideline requirements for harmonization
• Understand CFR-ICH alignment for global operations
• Access citation frequency data for risk prioritization

Endpoints:

• GET /v1/intelligence/regulations/{cfr} - CFR section details
• GET /v1/intelligence/ich/{guideline} - Complete ICH guideline
• GET /v1/intelligence/ich/{guideline}/{section} - Specific ICH section

4. Analytics and Trends

Retrieve industry-wide citation trends, frequency analysis, and regulatory focus areas.

Use Cases:

• Identify emerging regulatory focus areas
• Benchmark facility citation rates against industry
• Plan internal audit schedules based on trending citations
• Support strategic compliance planning

Endpoint: GET /v1/analytics/trends

Example:

curl -X GET "https://LAMBDA_URL/v1/analytics/trends?time_period=1y&product_type=drug" \
  -H "Content-Type: application/json"

Response Highlights:

• Trending CFR citations with rank changes
• Event type frequency and severity distribution
• Geographic trends across regions
• Regulatory focus areas (CFR parts and subparts)

Entity Resolution Explained

What is Entity Resolution?

Entity resolution is the process of identifying and linking related entities across different data sources. The KG Intelligence API uses entity resolution to:

1. Normalize Event Descriptions: Map natural language event descriptions to standardized event types
2. Link Regulations: Connect events to applicable CFR sections and ICH guidelines
3. Find Similar Observations: Use semantic search to identify related FDA 483 citations
4. Establish Relationships: Create connections between regulations, guidelines, and events

How It Works

┌─────────────────────────────────────────────────────────────────┐
│                    User Input (Natural Language)                 │
│  "Spider found in manufacturing area during production"          │
└─────────────────────┬───────────────────────────────────────────┘
                      │
                      ▼
┌─────────────────────────────────────────────────────────────────┐
│                    Entity Resolver                               │
│  ┌──────────────────────────────────────────────────────────┐   │
│  │ 1. Text Analysis & Keyword Extraction                    │   │
│  │    Extract: "spider", "manufacturing area", "production" │   │
│  └──────────────────────────────────────────────────────────┘   │
│  ┌──────────────────────────────────────────────────────────┐   │
│  │ 2. Event Taxonomy Matching                               │   │
│  │    Match to: "pest_control" (confidence: 0.97)           │   │
│  └──────────────────────────────────────────────────────────┘   │
│  ┌──────────────────────────────────────────────────────────┐   │
│  │ 3. Regulation Mapping                                    │   │
│  │    Map to: 21 CFR 211.56 (Sanitation)                    │   │
│  └──────────────────────────────────────────────────────────┘   │
│  ┌──────────────────────────────────────────────────────────┐   │
│  │ 4. Semantic Search (Similar Observations)                │   │
│  │    Find: Similar 483 citations with "pest" issues        │   │
│  └──────────────────────────────────────────────────────────┘   │
└─────────────────────┬───────────────────────────────────────────┘
                      │
                      ▼
┌─────────────────────────────────────────────────────────────────┐
│                    Structured Response                           │
│  - Classification: pest_control (category: sanitation)           │
│  - Applicable Regulations: 21 CFR 211.56, 21 CFR 211.25          │
│  - Similar Observations: 3 FDA 483s with semantic similarity     │
│  - Evidence Sources: Full provenance chain                       │
└─────────────────────────────────────────────────────────────────┘

Entity Resolution Components

Component	Purpose	Technology
Event Taxonomy	Standardized event type classification	Curated taxonomy with 30 event types
CFR Mappings	Event → CFR section relationships	SME-curated mappings by product type
ICH Cross-References	CFR ↔ ICH guideline alignment	Harmonization mappings with alignment scores
Semantic Embeddings	Similar observation search	OpenAI text-embedding-3-small model
Evidence Framework	Source provenance tracking	P0 non-negotiable requirement

Evidence Framework (P0 Non-Negotiable)

Every response from the KG Intelligence API includes complete evidence provenance. This is a P0 non-negotiable requirement ensuring transparency and traceability.

Evidence Sources

All assertions in API responses are backed by verifiable sources:

{
  "evidence_sources": [
    {
      "source_type": "event_taxonomy",
      "source_id": "event-taxonomy-v2.0.jsonl",
      "retrieval_method": "keyword_match",
      "confidence": 0.97
    },
    {
      "source_type": "fda_483_database",
      "source_id": "fda-483-embeddings-2020-2024",
      "retrieval_method": "semantic_search",
      "confidence": 0.89,
      "documents_retrieved": 3
    }
  ]
}

Evidence Chain

The evidence chain tracks integrity and coverage:

{
  "evidence_chain": {
    "chain_integrity": "verified",
    "evidence_coverage": 0.94,
    "provenance_complete": true,
    "sources_verified": 4
  }
}

Evidence Chain Status

Status	Meaning	Action Required
verified	All sources verified and complete	None - full confidence
partial	Some sources unavailable or incomplete	Review response; may have gaps
unverified	Sources could not be verified	Do not rely on response; contact support

Source Types

Source Type	Description	Confidence Level
event_taxonomy	Curated event type taxonomy	High (0.90-1.0)
cfr_regulations	Official CFR text from GPO	Absolute (1.0)
ich_guidelines	Official ICH guideline documents	Absolute (1.0)
fda_483_database	Historical FDA 483 observations	High (0.85-0.99)
cfr_mapping	SME-curated CFR-event mappings	High (0.90-1.0)
semantic_search	AI-powered similarity search	Medium-High (0.70-0.95)

ICH Guidelines Cross-References

The Knowledge Graph includes complete ICH guidelines with CFR cross-references:

Supported Guidelines

Guideline	Title	Sections	Use Cases
ICH Q7	Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients	19 main sections	API manufacturing, GMP compliance, facility design
ICH Q9	Quality Risk Management	7 main sections	Risk assessment, FMEA, validation prioritization
ICH Q10	Pharmaceutical Quality System	5 main sections	Quality system design, lifecycle management

CFR-ICH Alignment

ICH guidelines are harmonized with CFR requirements:

ICH Q7 Section 4.4 (Sanitation)
    ↓ (direct mapping, alignment: 0.95)
21 CFR 211.56 (Sanitation)
    ↓ (supporting mapping, alignment: 0.78)
21 CFR 211.67 (Equipment Cleaning)

Mapping Types

Mapping Type	Description	Example
Equivalent	Near-identical requirements	ICH Q7 2.2 ↔ 21 CFR 211.22 (Quality Unit)
Related	Closely aligned requirements	ICH Q7 4.4 ↔ 21 CFR 211.56 (Sanitation)
Supporting	Complementary requirements	ICH Q7 12.1 ↔ 21 CFR 211.100 (Procedures)
Prerequisite	Foundational requirement	ICH Q7 4.4 → 21 CFR 211.42 (Facility Design)

Architecture

Lambda Function URLs (Direct Access)

The KG Intelligence API uses Lambda Function URLs for direct, low-latency access without API Gateway overhead.

Dev0 Environment URLs:

• Intelligence API: https://tmhyumqw2v24ddgj4lhis6cjay0vriqb.lambda-url.us-east-1.on.aws
• Entity Resolver: https://rr2xf4ngyteystdz3ok5eb7lga0bfage.lambda-url.us-east-1.on.aws

Benefits:

• Lower Latency: Direct Lambda invocation (50-100ms faster than API Gateway)
• Simplified Architecture: No API Gateway management overhead
• Cost Efficiency: No API Gateway request charges
• Native AWS Integration: Seamless integration with AWS services

System Architecture

┌─────────────────────────────────────────────────────────────────┐
│                        Client Application                        │
└─────────────────────┬───────────────────────────────────────────┘
                      │
                      │ HTTPS Request (Lambda Function URL)
                      │
                      ▼
┌─────────────────────────────────────────────────────────────────┐
│                  KG Intelligence Lambda                          │
│  ┌──────────────────────────────────────────────────────────┐   │
│  │ API Route Handler                                        │   │
│  │  - /v1/intelligence/classify                             │   │
│  │  - /v1/intelligence/investigate                          │   │
│  │  - /v1/intelligence/regulations/{cfr}                    │   │
│  │  - /v1/intelligence/ich/{guideline}                      │   │
│  │  - /v1/analytics/trends                                  │   │
│  └──────────────────┬───────────────────────────────────────┘   │
│                     │                                            │
│                     ▼                                            │
│  ┌──────────────────────────────────────────────────────────┐   │
│  │ Entity Resolver Service (Lambda)                         │   │
│  │  - Event classification                                  │   │
│  │  - Regulation mapping                                    │   │
│  │  - Semantic search                                       │   │
│  └──────────────────┬───────────────────────────────────────┘   │
└────────────────────┬┴──────────────────────────────────────────┘
                     │
        ┌────────────┼────────────┐
        │            │            │
        ▼            ▼            ▼
┌──────────────┐ ┌──────────────┐ ┌──────────────┐
│   DynamoDB   │ │  OpenSearch  │ │  OpenAI API  │
│  (Knowledge  │ │  (Semantic   │ │ (Embeddings) │
│    Graph)    │ │   Search)    │ │              │
└──────────────┘ └──────────────┘ └──────────────┘

Data Storage

Component	Storage	Purpose
Event Taxonomy	DynamoDB	Event types and CFR mappings
CFR Regulations	DynamoDB	Complete Title 21 CFR text
ICH Guidelines	DynamoDB	Q7, Q9, Q10 full content
FDA 483 Observations	OpenSearch	Semantic search with embeddings
Citation Analytics	DynamoDB	Aggregated frequency data

Available Endpoints

Endpoint	Method	Authorization	Purpose
/v1/intelligence/classify	POST	Starter+	Event classification and CFR mapping
/v1/intelligence/investigate	POST	Pro+	Comprehensive investigation with risk assessment
/v1/intelligence/regulations/{cfr}	GET	Starter+	CFR section details with ICH cross-references
/v1/intelligence/ich/{guideline}	GET	Starter+	Complete ICH guideline with CFR mappings
/v1/intelligence/ich/{guideline}/{section}	GET	Starter+	Specific ICH section with implementation guidance
/v1/analytics/trends	GET	Pro+	Citation trends and regulatory analytics

Authorization Tiers

Tier	Included Endpoints	Rate Limit	Price
Starter	Classify, CFR Lookup, ICH Lookup	1,000/day	Contact Sales
Pro	All Starter + Investigate, Analytics	10,000/day	Contact Sales
Enterprise	All Pro + Unlimited, Export, Forecasts	Unlimited	Contact Sales

Getting Started

1. Classify Your First Event

Start with event classification to understand the API's capabilities:

curl -X POST "https://tmhyumqw2v24ddgj4lhis6cjay0vriqb.lambda-url.us-east-1.on.aws/v1/intelligence/classify" \
  -H "Content-Type: application/json" \
  -d '{
    "event": "Annual product review not completed for three batches",
    "product_type": "drug"
  }'

Expected Response:

• Event type: documentation_deficiency
• Category: documentation
• Applicable CFR: 21 CFR 211.192 (Production record review)
• Confidence: High (0.90+)

2. Investigate a Complex Event

For major deviations, use the comprehensive investigation endpoint:

curl -X POST "https://tmhyumqw2v24ddgj4lhis6cjay0vriqb.lambda-url.us-east-1.on.aws/v1/intelligence/investigate" \
  -H "Content-Type: application/json" \
  -d '{
    "event": "Out-of-specification test result for dissolution, investigation incomplete",
    "product_type": "drug",
    "include_similar": true,
    "include_ich": true,
    "include_risk_assessment": true
  }'

Expected Response:

• Event classification with high confidence
• Multiple applicable CFR sections (211.160, 211.165, 211.192)
• 3-5 similar FDA 483 observations
• Relevant ICH Q9 (risk management) and Q7 (laboratory controls) sections
• AI-powered risk assessment with recommended actions

3. Reference Regulations

Look up CFR sections for procedure development:

curl -X GET "https://tmhyumqw2v24ddgj4lhis6cjay0vriqb.lambda-url.us-east-1.on.aws/v1/intelligence/regulations/21-CFR-211.160" \
  -H "Content-Type: application/json"

4. Explore ICH Guidelines

Access ICH guideline sections for harmonization:

curl -X GET "https://tmhyumqw2v24ddgj4lhis6cjay0vriqb.lambda-url.us-east-1.on.aws/v1/intelligence/ich/Q7/12.4" \
  -H "Content-Type: application/json"

5. Monitor Trends

Track regulatory focus areas for strategic planning:

curl -X GET "https://tmhyumqw2v24ddgj4lhis6cjay0vriqb.lambda-url.us-east-1.on.aws/v1/analytics/trends?time_period=1y&product_type=drug&limit=10" \
  -H "Content-Type: application/json"

Common Use Cases

Quality Assurance

• Deviation Classification: Classify deviations and identify applicable regulations
• CAPA Support: Research similar observations for root cause analysis
• Internal Audit Planning: Use trending citations to focus audit schedules
• Risk Assessment: Generate data-driven risk assessments for quality events

Regulatory Affairs

• Inspection Preparation: Research trending citations and likely focus areas
• Submission Support: Reference CFR and ICH requirements for submissions
• Regulatory Intelligence: Monitor shifting regulatory priorities
• Global Harmonization: Map CFR requirements to ICH guidelines

Quality Control / Laboratory

• OOS Investigation: Find similar OOS observations and regulatory requirements
• Method Validation: Reference ICH Q7 requirements for analytical methods
• Laboratory Controls: Map laboratory events to 21 CFR 211.160 requirements
• Data Integrity: Research data integrity citations and best practices

Executive Leadership

• Compliance Dashboards: Track citation trends vs. industry benchmarks
• Risk Reporting: Quantify regulatory risk exposure
• Strategic Planning: Identify emerging compliance priorities
• Resource Allocation: Prioritize compliance investments based on data

Best Practices

1. Use Specific Event Descriptions

Good: "Temperature excursion in stability chamber - readings exceeded 30°C for 4 hours" Better: Provides context for accurate classification and similar observation matching

Poor: "Temperature problem" Why: Vague description reduces classification confidence

2. Specify Product Types When Known

{
  "event": "Particulate matter found in finished product",
  "product_type": "drug"
}

Product type filtering returns only applicable regulations, reducing noise.

3. Review Evidence Sources

Always check the evidence_sources and evidence_chain fields:

{
  "evidence_chain": {
    "chain_integrity": "verified",
    "evidence_coverage": 0.94,
    "provenance_complete": true
  }
}

If chain_integrity is not "verified", review the response carefully.

4. Adjust Similarity Threshold for Investigation

• High Threshold (0.85+): Precise matches for specific precedent research
• Medium Threshold (0.75-0.84): Balanced results for general investigation
• Low Threshold (0.65-0.74): Broader research for exploratory analysis

5. Leverage Risk Assessment Data

The AI-powered risk assessment includes:

• Risk Level: Critical, High, Medium, Low
• Impact Areas: Product quality, regulatory compliance, patient safety
• Recommended Actions: Prioritized corrective actions
• Citation Frequency: Historical data on similar citations

Use this data to support CAPA decisions and resource allocation.

Performance and Reliability

Response Times

Endpoint	Typical Latency	Notes
Classify	200-500ms	Depends on text complexity
Investigate	1.0-2.5s	Includes semantic search and risk assessment
CFR Lookup	100-300ms	Cached responses <50ms
ICH Guideline	200-500ms	Full guideline larger response
ICH Section	100-300ms	Single section faster
Analytics Trends	600-1200ms	Aggregation over large dataset

Caching

Content Type	Cache Duration	Notes
CFR Regulations	7 days	Quarterly updates
ICH Guidelines	7 days	Infrequent updates
Classification Results	24 hours	Based on text hash
Analytics Trends	24 hours	Weekly data updates
Similar Observations	24 hours	Static historical data

Availability

• SLA: 99.9% uptime (Enterprise tier)
• Monitoring: CloudWatch metrics and alarms
• Failover: Multi-AZ Lambda deployment
• Backup: DynamoDB and OpenSearch automated backups

Data Currency

Data Source	Update Frequency	Current Coverage
FDA 483 Observations	Weekly	2020-2024 (15,000+ observations)
CFR Regulations	Quarterly	Title 21 (April 2024)
ICH Guidelines	As published	Q7, Q9, Q10 (latest versions)
Citation Analytics	Weekly	Rolling 5-year window

Support and Resources

• Documentation: Full API reference at docs.orchestraprime.com
• Support: support@orchestraprime.com
• Sales: sales@orchestraprime.com
• Status Page: status.orchestraprime.com (planned)

Next Steps

1. Explore Endpoints: Review detailed API endpoint documentation
2. Test Integration: Use dev0 environment for testing (URLs provided above)
3. Contact Sales: Discuss subscription tiers and pricing
4. Review Use Cases: Identify high-value use cases for your organization
5. Plan Deployment: Integrate KG Intelligence API into quality and regulatory workflows

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Ready to get started? Begin with the Classify Event endpoint to see the power of the Knowledge Graph in action.

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See Also

• Platform Intelligence Overview - How the KG Intelligence API connects to 483 inspections, Event Taxonomy, eCFR, ICH guidelines, and Warning Letters
• Event Taxonomy - Deep dive into the 30 event types and entity resolution algorithm
• 483 Inspection Intelligence - The 483 data pipeline that feeds the Knowledge Graph
• Supplier Monitoring Guide - Practical workflows for compliance monitoring using both 483 and KG APIs