What is G-RLCA?
G-RLCA (Governed Regulatory Loop Agent) is a closed-loop AI safety and compliance architecture. Unlike standard AI assistants that blindly execute actions, G-RLCA sits between the Large Language Model agent and your production pharma database or artwork generation tools.
Before any action is staged or written to database storage, G-RLCA evaluates the risk score of the proposed action against regulatory frameworks (such as European Medicines Agency EMA standards and FDA 21 CFR Part 11). If the risk exceeds safety thresholds, the engine intercepts the agent and pauses execution for mandatory human approval.
User Interface Workflow (Frontend)
The dashboard interface gives regulatory auditors complete visibility into what the AI agent is thinking and doing in real time:
Left Panel: Instruction & Presets
- Unstructured Input: Type regulatory change requests or paste raw EMA/FDA guideline updates.
- Preset A (Compliant): Triggers a high-contrast label color update (#FFFFFF text on Pantone 186 C red). Passes governance checks.
- Preset B (Non-Compliant): Triggers a poor-contrast label update (#000000 black text on dark red). Intercepted and blocked by G-RLCA rules.
Right Panel: Live Trace & HITL Queue
- Trace Stream: View the agent's real-time step execution, vector retrieval, and tool selection.
- Risk Readout: Shows calculated risk scores vs. pre-configured policy thresholds (e.g., Score 75 / Threshold 50).
- HITL Decision Interlock: When paused, auditors click Approve & Execute or Reject Action to resume or kill the loop.
Execution Lifecycle (Backend)
Every instruction follows a strict five-stage governance pipeline back-end process:
The agent converts the input request into a semantic query, sweeping local ChromaDB vector tables to pull active EMA/FDA packaging guidelines and brand color standards.
Before executing any tool (e.g., stage_label_color_change), the G-RLCA policy engine inspects the proposed parameters (color values, legibility contrast ratios, drug strength rules) and assigns a numerical risk score (0 to 100).
If Risk Score > Threshold, execution is frozen instantly. A cryptographic request session ID is created and queued for Human-in-the-Loop review.
Upon human review, an approval HTTP callback unlocks the session thread. The agent finishes tool execution; if rejected, the action is safely rolled back without changing database state.
An immutable audit entry recording user timestamp, agent prompt, risk metrics, parameter payload, and human sign-off ID is appended to the regulatory audit ledger.
Governance Decision Payload Spec
Below is an example JSON trace payload emitted by the backend during a high-risk governance intercept:
{
"session_id": "sess_2026_0727_981a",
"step": "governance_block",
"tool_name": "stage_label_artwork_revision",
"risk_assessment": {
"risk_score": 85,
"risk_threshold": 50,
"violation_reason": "Low legibility contrast ratio (1.2:1) fails EMA 2026-081 safety standard"
},
"arguments": {
"product_id": "CARD-50MG-01",
"background_hex": "#C8102E",
"text_hex": "#000000"
},
"hitl_request_id": "hitl_req_3310"
}