AuditIQ
The Global Lens for GMP Audits
Transform inspection data into inspection readiness with a centralized intelligence platform for Quality, Compliance, and Regulatory teams.
Uncover inspection trends, investigator patterns, recurring compliance risks, and company benchmarks to prepare smarter and respond faster.
THE PROBLEM
Inspection Intelligence
Shouldn't Be This Hard
Inspection data from USFDA, EMA, and MHRA scattered across multiple portals with no unified view
Difficult to identify recurring compliance risks and critical cGMP observations before they escalate
Limited visibility into investigator-specific patterns, strictness tiers, and inspection focus areas
No benchmarking intelligence to compare company performance against industry peers and top players
Manual review of historical inspection data consumes QA and Regulatory resources that should drive readiness
AuditIQ centralizes global inspection intelligence across agencies
One platform covering USA, EU, and UK inspection data - helping teams identify trends, benchmark industry peers, and strengthen inspection readiness without the manual effort
- Global inspection database: USFDA 483s, EudraGMDP, and MHRA GMDP in one place
- System-based cGMP analysis across all six FDA compliance frameworks
- Deep Investigator intelligence built from 8+ years of real inspection records
- Top 20 recurring issues by manufacturing segment and geography
- Top 10 company & investigator benchmarking intelligence by geography
- Structured inspection guides for FDA, EMA & MHRA readiness
What AuditIQ Delivers
A structured inspection intelligence layer for QA, QC, Regulatory, Compliance, and senior leadership teams preparing for Inspection, Internal Audit, or Remediation Planning.
Multi-Agency Global Database
Unified search across USFDA 483 Observations, EU EudraGMDP Compliance & Deficiency Certificates, and UK MHRA GMDP records - all in one platform.
Searchable Inspection Data
Find Observations by Company, Investigator, Year, Establishment Type, cGMP Systems, Country, FEI, Certificate, Inspection Date, Keywords: Data Integrity, OOS, etc.
System-Based cGMP Intelligence
Classify and analyze observations across all six FDA cGMP Systems to identify which areas are repeatedly vulnerable during inspections across agencies.
Predictive Audit Focus
Use Investigator Trends, recurring issue reports, and inspection guides to design targeted audits and remediation plans before the next inspection occurs.
Competitive Benchmarking
Compare your inspection performance against Top 10 Companies in your segment. Understand where peers excel and where your gaps are most exposed.
Core Modules
Purposefully designed to provide insight without exposing proprietary intelligence modules
Global Inspection Database
The only pharma intelligence platform unifying USFDA, EMA EudraGMDP, and MHRA GMDP inspection data, enabling searchable analysis across thousands of companies and events since 2018.
Explore
cGMP Six-System Checklist
Structured readiness checklists mapped to all six FDA cGMP systems — Quality System, Laboratory Controls, Production, Materials, Facilities & Equipment, and Packaging & Labeling. Identify gaps before inspectors do.
Explore
Top 20 Recurring Issues
Curated intelligence reports highlighting the most frequently cited compliance challenges across API, FDF, OSD and sterile manufacturing segments— for India and USA-based sites.
Explore
Investigator Profile
In-depth profiles for every FDA investigator covering focus areas, strictness tier, frequently cited cGMP systems, co-inspection patterns, and full observation history 2018–2026.
ExploreInspection Guide
Step-by-step preparation playbooks for FDA inspections. Covers pre-inspection, during inspection and post-inspection best practices.
ExploreWarning Letter Database
Quickly access and review FDA warning letters through a simplified search experience. Filter by company, year to learn from industry precedents and avoid repeat patterns.
Explore