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🔧 STATGRAPHICS

STATGRAPHICS

The World's Leading Software for Statistics and Data Analysis.

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Overview

STATGRAPHICS is a software product for statistical data analysis. For regulated customers, it provides features to support 21 CFR Part 11 compliance, including the ability to add passwords and user signatures to files (StatFolios) and the automatic creation of an audit trail to record changes.

✨ Key Features

  • Password protection for files
  • User electronic signatures
  • Automatic audit trail creation
  • Comprehensive statistical analysis tools
  • Data visualization

🎯 Key Differentiators

  • Specific features to aid 21 CFR Part 11 compliance
  • User-friendly interface for statistical analysis
  • Strong focus on data visualization

Unique Value: Provides robust statistical analysis tools with built-in features like audit trails and e-signatures to help regulated companies comply with 21 CFR Part 11.

🎯 Use Cases (3)

Analyzing manufacturing process data in a compliant manner Maintaining integrity of statistical reports for regulatory submission Documenting data analysis with secure records and signatures

✅ Best For

  • Used by companies regulated by the FDA, such as pharmaceutical and medical device manufacturers.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Not a QMS; it is a data analysis tool, and compliance depends on how the user implements it within their validated systems.

🏆 Alternatives

Minitab JMP IBM SPSS

Offers specific, built-in compliance features that other general statistical packages may lack, reducing the validation burden on the user.

💻 Platforms

Desktop

✅ Offline Mode Available

🛟 Support Options

  • ✓ Email Support
  • ✓ Phone Support
  • ✓ Dedicated Support (Varies tier)

🔒 Compliance & Security

✓ Supports FDA 21 CFR Part 11

💰 Pricing

Contact for pricing

✓ 30-day free trial

Visit STATGRAPHICS Website →

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