Continuous Intelligent
GxP Audits
Maximum automation, minimum compliance burden.
Automate vendor reviews and compliance gaps with the first AI auditor specifically trained for regulated GxP environments.
Collecting vendor qualification packages and evidence files
Site Master Files | Training Logs | SOPs | CAPA Records | Certificates
Why Choose
cIGA?
cIGA transforms scattered evidence, late findings, and manual follow-up into continuous audit intelligence, connected traceability, and inspection-ready reporting.
Vendor Audit Hub
Run AI-driven vendor audits continuously and detect compliance risks before they become issues.
Regulatory Intelligence
Map internal controls to global regulations and make interpretation faster, clearer, and scalable.
Audit-Ready Report
Generate inspection-ready reports with one click. Complete audit trails, evidence mapping, and regulatory cross-references.
Before & After cIGA
cIGA replaces static questionnaires, limited audit bandwidth, and outdated compliance checks with 24/7 Digital Auditors that validate, score, and report in real time, reducing audit team workload by 80%.
Business-Hours-Only Audits
Audits run only when human auditors are available, creating bottlenecks and leaving compliance gaps unmonitored overnight and on weekends.
Limited Audit Capacity
Teams can handle only a limited number of audits simultaneously, creating backlogs and delaying vendor qualification cycles.
Stale Audit Questionnaires
Static questionnaires become outdated quickly and fail to reflect the latest regulatory changes or industry best practices.
Overwhelmed Audit Teams
Manual audit prep, evidence collection, and follow-up consume 80% of audit team capacity, leaving little time for high-value analysis.
24/7 Digital Auditors
Digital Auditors conduct audits around the clock, validating all responses in real time and scoring them, with no downtime and no delays.
Unlimited Simultaneous Audits
Run an unlimited number of audits concurrently with no queuing or capacity constraints, accelerating vendor qualification at scale.
Dynamic Audit Questions
cIGA generates audit questions tailored to each vendor and domain, based on the latest regulatory and best practice expectations. No more stale, static questionnaires.
80% Workload Reduction
Automated pre-audit prep, real-time validation, and intelligent reporting reduce audit team workload by 80%, freeing them for strategic, high-value work.
How to Get Started
Replace fragmented audit work with a cleaner, faster, and more inspection-ready flow.
24/7 AI auditors that never sleep, never queue.
Digital Auditors conduct audits around the clock, validating responses in real time, scoring findings, and supporting an unlimited number of simultaneous audits with zero wait.
Start every audit with a head start, not a blank page.
cIGA generates pre-audit reports from publicly available information including regulatory actions, certifications, and recalls, giving your team a strong foundation before the actual audit begins.
Form 483 issued March 2024 · Data integrity observations
Certificate expires in 30 days · Renewal not yet filed
Voluntary Class II recall · Sterility assurance concern
AI-generated audit questions that stay current, always.
cIGA generates audit questions tailored to each vendor and domain based on the latest regulatory and best practice expectations, replacing static questionnaires that become stale in today's fast-moving digital age.
How does your facility handle cold chain deviations per EU GDP Annex 5?
Describe your CAPA escalation workflow for critical deviations under ICH Q10.
What automated controls ensure 21 CFR Part 11 compliance for electronic batch records?
Questions adapt to vendor, domain & latest regulations
80% less manual work. 100% regulatory confidence.
Automated pre-audit prep, real-time validation, and intelligent reporting reduce audit team workload by 80%, while every Digital Auditor stays current on the latest industry, regulatory, and corporate policy requirements.
Reduction in audit team workload
Audit teams now focus on strategic analysis, not paperwork
Intelligent
AI Features
cIGA enables continuous compliance, autonomous auditing, and AI-driven governance to transform how regulated industries operate.
Uses AI to interpret regulatory frameworks and map them directly to your systems, ensuring continuous alignment with evolving compliance requirements.
Smart
Decision Engine
Intelligent Compliance Engine
Real-Time
Scoring
Continuous Governance
1-Click
Audit Access
Unified Audit Layer
Zero
Manual Effort
Autonomous Auditing
Instant
Impact Analysis
Dynamic Change Control
Proactive
Risk Detection
Predictive Risk Intelligence
Decision Engine
Intelligent Compliance Engine
Uses AI to interpret regulatory frameworks and map them directly to your systems, ensuring continuous alignment with evolving compliance requirements.
Trusted By
Industry Leaders
Leading pharmaceutical, biotechnology, and life sciences organizations rely on xLM to accelerate compliance, modernize validation, and drive operational excellence through Continuous Intelligence.
Thena Alagappan
Head of IT at SCA Pharmaceuticals
Insights From
Industry Experts
Explore expert perspectives on AI, quality, compliance, manufacturing, validation, and digital transformation. Discover practical insights, emerging trends, and real-world strategies shaping the future of GxP manufacturing.
Reengineering GxP Vendor Audits for the AI Era
Reengineer GxP vendor audits with AI-powered continuous intelligence to scale compliance, reduce audit cycles, improve vendor oversight, and ensure readiness.
Explore All Insights
Dive deeper into our complete library of articles, case studies, and industry insights.
View All Blogs
Questions We Hear
Most
cIGA (Continuous Intelligent GxP Audits) is an AI-driven platform and methodology designed to transform traditional vendor audits from manual, episodic exercises into continuous, intelligent compliance workflows. Unlike traditional methods that are limited by Subject Matter Expert (SME) availability, cIGA uses AI agents to conduct structured interviews and provide real-time compliance validation. The data from the interviews is organized and presented to the SMEs for review and to take further action to complete the audit. This approach reduces the friction, increases efficiency, and enforces compliance much better than what's done today.