How FieldGuardian™ Works

A technical overview of our secure, zero-integration compliance solution

The FieldGuardian™ Workflow

Our browser-based overlay adds AI-powered compliance checking to your existing systems with zero integration requirements

1. Form Detection

The browser extension automatically detects any quality form field in ServiceNow, Veeva, Oracle SCM, or other enterprise platforms using a combination of DOM analysis and OCR technology.

This works with:

  • Deviation records
  • CAPA responses
  • Batch documentation
  • Complaint handling
  • Investigation forms
2. Secure Processing

When a user clicks the "Check GxP" button next to a form field, the extension:

  • Parses the text content client-side
  • Encrypts the data using WebCrypto APIs
  • Securely transmits to our FieldGuardian™ microservice

All data is encrypted in transit and no PII is retained beyond the analysis session.

3. Compliance Analysis

Our AI engine processes the content by:

  • Comparing against your uploaded SOP snippets
  • Checking against EMA/FDA regulatory clauses
  • Evaluating for technical compliance language
  • Identifying potential audit risks

The system returns:

  • Compliance rating (Green / Amber / Red)
  • Up to three precise, actionable fixes
  • "Why" links back to source SOP or regulation
4. Human-in-the-Loop

We maintain full human control:

  • No automatic write-back to your systems
  • Users manually copy improved suggestions
  • Manager dashboard logs all overrides
  • One-click pushes new training examples
  • Fully auditable (Annex 11, GAMP 5 compliant)

This maintains the regulatory chain of responsibility while dramatically improving efficiency.

Technical Architecture

Enterprise-grade security with minimal footprint

Client Components
  • Browser Extension (Chrome, Firefox, Edge)
  • Content Script for DOM analysis
  • WebCrypto for secure encryption
  • Optional OCR engine for legacy systems
Server Components
  • Secure API microservice
  • Vector database for SOP knowledge
  • LLM with regulatory training
  • Audit-ready logging system
  • Manager dashboard for oversight
Security & Compliance Features
  • End-to-end encryption
  • "No training" flag to OpenAI
  • PII detection and masking
  • Payloads purged in <10 seconds
  • GAMP 5 Category 1 (Non-configurable)
  • Part 11 and Annex 11 compliant
  • Immutable audit logs
  • Validation documentation available

Implementation Timeline

From setup to full deployment in days, not months

1
Day 1: Extension Installation

Install the FieldGuardian™ extension from the Chrome Web Store in 90 seconds per user. No IT approvals required as it's a user-level installation with no system access.

2
Day 1: SOP Upload

Upload your SOP ZIP files to the secure manager dashboard. Our system automatically extracts and indexes relevant compliance clauses (20 minutes).

3
Day 2-3: User Training

Brief 30-minute training session for users to understand the compliance ratings and how to incorporate suggestions into their workflow.

4
Day 4+: Continuous Improvement

Manager overrides automatically feed back into the system, improving accuracy by 1-2 percentage points per 1,000 uses. Quarterly fine-tuning to incorporate new regulations.

Ready to see FieldGuardian™ in action?

Schedule a personalized demo with our compliance experts.

Ready to submit regulated forms with 100% approval?