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ChatGMP

Your AI GMP Compliance Officer

The first AI assistant trained to navigate, enforce, and accelerate GMP compliance and lab quality systems.

AI-Powered Compliance. Human-Speed Execution.

The Smartest Way to Run a GMP-Compliant Lab

From SOPs to QA — Your AI Co-Pilot for Manufacturing Excellence

ChatGMP transforms complex regulatory requirements into actionable guidance. Built specifically for pharmaceutical, biotech, and manufacturing environments, it ensures your operations stay compliant, efficient, and audit-ready.

GMP-Native AI Intelligence

Unlike generic AI assistants, ChatGMP is trained exclusively on FDA, ICH, EMA guidelines, and pharmaceutical best practices. Every response is compliance-aware and audit-ready.

🎯 Comprehensive Use Cases

ChatGMP adapts to every role in your GMP-compliant organization

Regulatory Assistant

Navigate complex regulatory landscapes with instant, accurate guidance.

  • Summarizes FDA/ICH/EMA guidelines - Get clear interpretations of complex regulations
  • Cross-checks lab documentation vs SOPs - Ensure consistency across procedures
  • Tracks CAPA, audit readiness, deviation reports - Stay prepared for inspections

LabOps & Quality Control

Empower your lab staff with step-by-step GMP guidance and quality assurance.

  • Helps junior lab staff follow GMP rules step-by-step - Reduce training time
  • Suggests protocol corrections and warns of violations - Prevent non-compliance
  • Automates logbook analysis, training reminders, traceability reports - Streamline operations

Manufacturing & Production AI

Optimize manufacturing processes with intelligent decision support and risk analysis.

  • Conversational batch record guidance - Real-time manufacturing support
  • Intelligent risk analysis and decision support (Deviation, OOS/OOT) - Smart problem-solving
  • Predictive alerts for calibration, maintenance, and QA checks - Preventive compliance

Internal Auditor Companion

Streamline audit processes with automated compliance checks and documentation review.

  • Answers: "Does this batch record meet CFR Part 11?" - Instant compliance verification
  • Helps build audit checklists - Comprehensive inspection preparation
  • Generates daily compliance summaries - Executive-ready reporting

Built for Pharmaceutical Excellence

Comprehensive Regulatory Knowledge

  • • FDA CFR Parts 11, 210, 211
  • • ICH Q7-Q10 Guidelines
  • • EMA GMP Guidelines
  • • USP Chapters & Monographs
  • • ISO 13485 & ISO 9001

Real-Time Compliance Assistance

  • • Instant SOP clarification
  • • Deviation guidance
  • • CAPA recommendations
  • • Change control support
  • • Validation protocols

Always Audit-Ready

  • • Inspection preparation
  • • Documentation review
  • • Gap analysis
  • • Compliance trending
  • • Risk assessment

Seamlessly Integrated Into Your Workflow

Manufacturing Floor

Batch record guidance during production
Real-time deviation handling
Equipment qualification support

Quality Laboratory

Method validation guidance
OOS/OOT investigation support
Stability study protocols

Regulatory Affairs

Submission preparation
Regulatory intelligence
Change control impact assessment

Executive Management

Compliance dashboards
Risk trending analysis
Audit readiness reports

Measurable Impact on Your Operations

75%

Faster Compliance Queries

Reduce time spent searching through regulations

90%

Audit Readiness Improvement

Proactive compliance monitoring and gap analysis

60%

Training Time Reduction

AI-guided learning for new staff

"ChatGMP has transformed our quality operations. What used to take hours of regulation searches now takes minutes."

— Dr. Sarah Mitchell, VP Quality Assurance, BioTech Solutions

Ready to Revolutionize Your GMP Compliance?

Join leading pharmaceutical and biotech companies who trust ChatGMP to maintain the highest standards of compliance and quality.

✅ Start Your Compliance Transformation

Experience the power of GMP-native AI in your lab today

Request Demo

Available for pharmaceutical, biotech, and medical device manufacturing • Fully validated and audit-ready