AI Apps

Continuous Intelligent GxP Audits (cIGA)

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cIGA: AI-Powered Continuous GxP Auditor for Vendor Audits

Built on advanced agentic AI and regulatory knowledge models, cIGA delivers speed, consistency, and audit readiness throughout the vendor audit lifecycle:

  • Conduct structured, AI-led audit interviews using standardized, GxP-aligned questioning frameworks
  • Validate vendor responses and uploaded evidence in real time against regulatory expectations
  • Generate defensible compliance scores, insights, and audit-ready reports without manual review delays

cIGA lets pharmaceutical companies run multiple vendor audits simultaneously, reducing reliance on SMEs while improving accuracy, traceability, and regulatory confidence.

Why cIGA?

  • Standardized GxP Coverage: Ensures consistent, comprehensive audit questioning across vendors and audit cycles.
  • Faster Audit Execution: Compresses audit timelines from weeks to days by eliminating manual interviews, travel, and scheduling bottlenecks.
  • Significant Cost Reduction: Eliminates on-site audit travel costs and reduces reliance on high-cost SMEs by enabling remote, AI-led vendor assessments.
  • Improved Scheduling Efficiency: Removes dependency on vendor Directors and VPs by enabling asynchronous audits that run on the vendorʼs timeline—not calendar availability.
  • Real-Time Compliance Intelligence: Instantly identifies gaps, risks, and remediation needs during the audit—not after.
  • Audit-Ready by Design: Automatically captures traceable evidence and structured justifications aligned to regulatory expectations.

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Years of GxP Experience
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Reduction in Audit Cycle Time
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Reduction in Audit Effort and Cost
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Standardized GxP Question Coverage
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Concurrent Audit Capacity
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Faster Audit Execution

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cIGA's AI features include:

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Automated User Requirements Specification Generation

Intelligent Audit Orchestration

Agentic AI coordinates end-to-end audits, managing workflows, sequencing questions, and tracking progress across multiple vendors simultaneously.

Intelligent Test Case Creation with Full Traceability

Adaptive GxP Questioning

AI-driven Auditor Agents retrieve domain-specific questions from curated knowledge bases and generate context-aware follow-ups based on vendor responses.

Adaptive Learning for Evolving Validation Needs

Real-Time Response & Evidence Validation

Validator Agents assess responses against GxP standards and optionally validate uploaded documents.

Autonomous Test Execution & Evidence Capture

Automated Scoring & Audit-Ready Reporting

Generates structured compliance scores, actionable recommendations, and regulator-ready PDF reports with embedded evidence and full traceability.