Platform Intelligence Overview
CTWise Platform Intelligence connects six data domains into a single, queryable compliance intelligence layer. This page explains how the pieces fit together and how to navigate between them.
Architecture at a Glance
+--------------------------+
| Platform Intelligence |
| Unified API |
+------+-------+-----------+
| |
+-----------------+ +------------------+
| |
+--------v--------+ +----------v----------+
| 483 Inspection | | KG Intelligence |
| Intelligence |<------- links -------->| API |
| /v1/483/* | | /v1/intelligence/*|
+--------+---------+ +----------+---------+
| |
+-------+--------+ +-------------++-----------+
| | | | |
+----v----+ +------v------+ +-------v---+ +------v----+ +----v------+
| FDA 483 | | Facility | | Event | | eCFR | | ICH |
| Observ. | | Risk Scores | | Taxonomy | | Pipeline | | Guidelines|
| 25,523 | | 1,411 FEIs | | 30 types | | 15 parts | | Q7/Q9/Q10 |
+---------+ +-------------+ +-----------+ +-----------+ +-----------+
|
+-----v------+
| Warning |
| Letters |
| 20 records |
+------------+
Data Domains
1. FDA 483 Inspection Intelligence
The foundation layer. 25,523 FDA Form 483 observations spanning fiscal years 2020--2024, covering every FDA-inspected facility type (drug, device, food, biologics).
| Dataset | Records | Source | Refresh |
|---|---|---|---|
| Observations | 25,523 | FDA Data Dashboard | Quarterly |
| Facilities | 1,411 unique FEIs | FDA Data Dashboard | Quarterly |
| CFR references | 1,411 mappings | Extracted from observations | On ingestion |
| Risk scores | Per-facility | Computed from observations | On ingestion |
API endpoints: Observation Search | Facilities | Risk Scores | CFR References | Analytics | Trending
Deep dive: 483 Inspection Intelligence
2. Event Taxonomy
A curated classification system that maps free-text FDA observations to structured event types, categories, and CFR regulations. Powers the entity resolution engine.
| Aspect | Detail |
|---|---|
| Event types | 30 canonical types (e.g., Pest Control Failure, Equipment Qualification Failure) |
| Categories | 8 (Sanitation, Equipment, Documentation, Personnel, Process Control, Materials, Laboratory, Quality Systems) |
| CFR mappings | Product-type-specific (drug, device, food, biologics) |
| Confidence | Per-type threshold (0.0--1.0) |
How it connects: When you call /v1/intelligence/classify, the Event Taxonomy is what resolves "spider found in warehouse" to Pest Control Failure under category Sanitation mapped to 21 CFR 211.56.
Deep dive: Event Taxonomy
3. eCFR Regulatory Pipeline
Full-text Title 21 CFR (Code of Federal Regulations) sourced from the official eCFR API. CTWise maintains structured, searchable, and vectorized copies of 15 CFR parts.
| CFR Part | Domain | Sections |
|---|---|---|
| Part 11 | Electronic Records | 15 |
| Part 58 | GLP (Nonclinical) | 41 |
| Part 111 | Dietary Supplements | 72 |
| Part 112 | Produce Safety | 37 |
| Part 113 | Thermally Processed Foods | 28 |
| Part 114 | Acidified Foods | 14 |
| Part 117 | Food Safety (HARPC) | 59 |
| Part 123 | Seafood HACCP | 16 |
| Part 210 | Drug CGMP (General) | 4 |
| Part 211 | Drug CGMP (Finished) | 95 |
| Part 212 | OTC Monograph Drugs | 18 |
| Part 600 | Biologics (General) | 8 |
| Part 610 | Biologics (Standards) | 18 |
| Part 820 | Quality System (Devices) | 50 |
| Part 1271 | HCT/P (Tissue) | 28 |
API endpoint: GET /v1/intelligence/regulations/{cfr_section}
4. ICH Guidelines
International Council for Harmonisation (ICH) quality guidelines integrated for cross-reference with FDA observations and CFR regulations.
| Guideline | Title | Sections |
|---|---|---|
| Q7 | GMP for Active Pharmaceutical Ingredients | ~30 |
| Q9 | Quality Risk Management | ~35 |
| Q10 | Pharmaceutical Quality System | ~31 |
API endpoints: GET /v1/intelligence/ich/{guideline} | GET /v1/intelligence/ich/{guideline}/{section}
5. Warning Letters and Enforcement
FDA Warning Letters linked to facilities by FEI number, creating an enforcement timeline from inspection to regulatory action.
| Dataset | Records | Coverage |
|---|---|---|
| Warning Letters | 20 | CDER, CFSAN, CDRH, CBER |
| Facility links | 10 matched FEIs | Cross-referenced with 483 data |
| CFR violations | 22 unique sections | Extracted from letter subjects |
Enforcement escalation path: 483 Inspection -> Warning Letter -> Consent Decree -> Seizure/Injunction
API endpoint: GET /v1/enforcement/timeline/{fei} (timeline view per facility)
6. Vectorized Intelligence
All five data domains are embedded as 1024-dimensional vectors (Amazon Titan v2) in S3 Vectors indexes, enabling semantic similarity search across the entire platform.
| Index | Vectors | Content |
|---|---|---|
483-citations | 25,522 | Raw 483 observations |
483-enriched | 25,523 | Observations + CFR + event type + risk score |
483-facilities | 1,411 | Facility profiles |
ich-guidelines | ~96 | ICH Q7/Q9/Q10 sections |
warning-letters | 20 | Warning letter content + metadata |
Semantic search powers the /v1/intelligence/investigate endpoint, which queries multiple indexes simultaneously to build evidence chains.
How the Pieces Connect
Investigation Flow
When you call POST /v1/intelligence/investigate with an observation like "Rusty equipment found near production line", this is what happens:
- Event Classification -- The Event Taxonomy classifies the text as
Equipment Maintenance Failure(category: Equipment) - CFR Mapping -- For drug manufacturing, this maps to
21 CFR 211.67(Equipment cleaning and maintenance) - eCFR Lookup -- Full regulation text retrieved from the eCFR pipeline for 21 CFR 211.67
- Similar 483s -- Semantic search against
483-enrichedvectors finds the most similar historical observations - Facility Context -- If an FEI is provided, facility risk score and inspection history are retrieved
- ICH Cross-Reference -- Related ICH Q7 sections on equipment maintenance are linked
- Warning Letter Check -- Warning letters citing 21 CFR 211.67 or the same facility are surfaced
- Evidence Assembly -- All sources are combined with provenance metadata into a single response
Cross-Domain Linking
| From | To | Link Type |
|---|---|---|
| 483 observation | Event Taxonomy | Event type classification |
| 483 observation | CFR section | Regulation mapping |
| 483 observation | Warning Letter | Same facility FEI |
| CFR section | eCFR full text | Regulation lookup |
| CFR section | ICH guideline | Cross-reference |
| Warning Letter | 483 observation | Related inspection numbers |
| Warning Letter | CFR section | Violations cited |
| Facility | 483 observations | All inspections by FEI |
| Facility | Warning Letters | Enforcement history by FEI |
| Facility | Risk Score | Computed from all events |
Navigation Guide
By Use Case
| I want to... | Start here |
|---|---|
| Search historical inspection observations | 483 Observation Search |
| Classify a quality event | KG Classify |
| Investigate an observation with full evidence | KG Investigate |
| Look up a specific CFR regulation | KG Regulations |
| Check a facility's risk profile | 483 Risk Scores |
| Monitor supplier compliance trends | Supplier Monitoring Guide |
| Find trending citation patterns | 483 Trending |
| Look up ICH guideline sections | KG ICH Guideline |
By Data Domain
| Domain | Concept Page | API Endpoints | Guide |
|---|---|---|---|
| 483 Inspections | 483 Intelligence | 8 endpoints | 483 Quickstart |
| Knowledge Graph | Event Taxonomy | 6 endpoints | KG Intelligence Overview |
| Enforcement | This page | Timeline API | Supplier Monitoring |
Related Reading
- 483 Inspection Intelligence -- Deep dive into the 483 data pipeline and how observations become intelligence
- Event Taxonomy -- How quality events are classified using the curated taxonomy
- KG Intelligence Overview -- Hands-on guide to the Knowledge Graph API with examples
- Supplier Monitoring -- How to build automated compliance monitoring workflows
- Risk Scoring Guide -- How facility risk scores are calculated