GxPrimeIntelligent Pharma Compliance Self-Assessment Platform

Pharma Self-Assessment • USFDA 483 Intelligence • Training Module

About GxPrime

GxPrime is a digital platform for pharma companies to self-evaluate compliance maturity, understand strengths and gaps, and learn from real-world FDA 483 observations.

Six Pharmaceutical Quality Systems

Evaluate your organization across all core systems. Each assessment produces overall score, strengths, gaps, weighted recommendations, and inspection readiness %.

Quality Units

Facilities & Equipment

Materials Management

Production

Packaging & Labeling

Laboratory Controls

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Six Quality Systems Self-Assessment

Evaluate compliance across Quality System, Facilities & Equipment, Materials Management, Production, Packaging & Labeling, and Laboratory Controls with scores, strengths, gaps, and weighted recommendations.

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FDA 483 Upload & Automated Intelligence

Upload USFDA 483 PDFs and instantly get concise summaries, key observations, themes, areas of concern, lessons learned, and action focus points.

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Training Programs (Video + PDFs)

Access modules on GMP fundamentals, Data Integrity, Six Quality Systems, Audit Readiness, FDA 483 themes, and Quality Culture with videos, guides, examples, and checklists.

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Company Compliance Scorecard

Generate a professional scorecard with overall compliance %, system-wise breakdown, risk exposure, priority focus areas, and improvement recommendations.

Why organizations use GxPrime

•Simple evaluation with powerful insights—no heavy QMS overhead.
•Strengthens audit preparedness by highlighting weaknesses before inspections.
•Improves awareness and quality culture with real FDA 483 patterns.
•Expert-designed content from senior pharma quality consultants.
•Works for small, medium, and growing pharma companies with minimal IT lift.

How GxPrime works

Choose a Quality System and complete the assessment.
Receive compliance scores and improvement insights.
Upload FDA 483 PDFs for instant summaries and learnings.
Access training modules to upskill teams.
Review your scorecard and plan improvements internally.

Target Users

Designed for teams across the pharma value chain.

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Pharmaceutical Manufacturing Units

Complete compliance evaluation for manufacturing facilities

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QA & QC Teams

Quality assurance and quality control professionals

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Leadership & Management Teams

Site management, executive leadership, and production operations leaders

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Training & Development Departments

HR and training teams building quality culture

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Contract Manufacturers (CMOs)

Contract manufacturing organizations

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New Pharma Startups

Emerging pharmaceutical companies

Pricing Plans

Choose the plan that fits your organization's needs. All plans include our comprehensive assessment platform with enterprise-grade security and support.

Starter

Custom

For teams starting their compliance self-assessment journey

✓Access to all Six Quality Systems assessments
✓Compliance score & insights
✓FDA 483 upload (1 per month)
✓Access to basic training modules

Professional

Custom

For growing organizations that need deeper intelligence

✓Unlimited FDA 483 uploads
✓Advanced insights & patterns
✓Complete training library
✓Multi-user access

Enterprise

Custom

For sites that need benchmarking and tailored onboarding

✓Site-level benchmarking
✓Custom training content
✓Priority support
✓Dedicated onboarding

Need a custom solution? We're here to help.

Frequently Asked Questions

Everything you need to know about GxPrime

GxPrime is a smart evaluation and learning tool designed for pharmaceutical compliance self-assessment. Unlike a full Quality Management System (QMS), GxPrime focuses on assessment, gap analysis, and training. It helps organizations identify improvement opportunities, strengthen audit preparedness, and promote quality culture without the complexity of a full QMS.

GxPrime covers all Six Pharmaceutical Quality Systems: Quality System, Facilities & Equipment, Materials Management, Production, Packaging & Labeling, and Laboratory Controls. Each assessment generates compliance scores, identifies strengths and gaps, and provides weighted recommendations.

Simply upload any USFDA 483 PDF document, and GxPrime will automatically generate a clear summary, extract key observations, identify root patterns and themes, highlight areas of regulatory concern, and provide actionable lessons learned. This helps leadership quickly understand the essence of observations without manual analysis.

GxPrime offers industry-standard training modules covering GMP Fundamentals, Data Integrity Principles, Six Quality Systems, Audit Readiness, Common FDA 483 Themes, and Quality Culture & Mindset. Each module includes explainer videos, PDF guides, examples, and checklists suitable for new hires, operators, supervisors, and quality professionals.

The scorecard provides an overall compliance percentage, breakdown by Quality System, risk exposure indicators, priority focus areas, and specific recommendations for improvement. This professional scorecard can be used for management reviews, team discussions, and internal quality meetings.

Yes! GxPrime is designed for companies of all sizes—small, medium, and growing pharma companies. It requires minimal IT complexity and can be easily adopted without extensive technical resources. The platform is simple to use while providing powerful insights.

Getting started is simple: choose a Quality System and complete the assessment, receive your compliance scores and improvement insights, upload FDA 483 PDFs for instant summaries, access training modules to improve team capability, and review your scorecard to plan improvements internally.

Absolutely! GxPrime is perfect for internal audits, mock inspections, and gap assessments. The platform helps identify weaknesses before regulatory inspections, strengthening your audit preparedness and ensuring your team is ready for real-world inspections.

Get in Touch

Interested in GxPrime? Fill out the form below and we'll contact you to discuss how our platform can help your organization maintain GxP compliance.