4DI — Data Integrity Tool

ALCOA++ & GxP Compliance Guide

Only for iPhone

Free · Designed for iPhone

iPhone

4DI is a professional helping tool built for pharmaceutical and life science professionals who work in GxP-regulated environments. Whether you are a quality manager, lab technician, validation specialist, or data integrity officer - 4DI puts essential data integrity knowledge and practical tools right in your pocket. 4DI bridges the gap between regulatory theory and everyday practice on the shop floor. ALCOA++ PRINCIPLES Explore all nine ALCOA++ data integrity principles through interactive, beautifully designed cards. Each principle includes a clear definition, real-world pharmaceutical examples showing both correct practices and common violations, and practical guidance you can apply immediately. Test your knowledge with a built-in quiz featuring 20+ questions. Track your scores over time and watch your expertise grow. REGULATORY FRAMEWORK EXPLORER Navigate the key regulatory frameworks that govern data integrity in pharma: - FDA 21 CFR Part 11 - EU GMP Annex 11 - MHRA GxP Data Integrity Guidance - PIC/S PI 041 - WHO Technical Report Series No. 996, Annex 5 - ICH Q7 Compare frameworks side-by-side to understand where they overlap and differ on critical topics like audit trails, electronic signatures, and risk-based approaches. Color-coded regional tags make orientation effortless. GEMBA WALK DOCUMENTATION Document data integrity observations directly on the production floor. The structured GEMBA Walk tool lets you: - Record observations with location, area, and detailed notes - Attach photos as supporting evidence - Use customizable checklists tailored to your site - Generate professional PDF and Word reports ready for your quality management system - All reports include confidentiality notices and professional formatting COMPREHENSIVE GLOSSARY Access 40+ data integrity terms and abbreviations covering ALCOA++ terminology, regulatory abbreviations (CFR, GMP, GLP, CSV, CSA), technical terms (audit trail, metadata, electronic signature), and quality system terms (CAPA, deviation, OOS, OOT). Each entry includes the full expansion, a clear definition, and context of use. Bookmark your most-used terms and discover something new every day with the Term of the Day feature. DESIGNED FOR PROFESSIONALS - Trilingual: Full support for English, German, and French - Dark and Light mode for comfortable use in any environment - Offline-first: All content available without an internet connection - Privacy-focused: All data stays on your device - No account required, no tracking, no ads 4DI is your daily companion for data integrity excellence in regulated environments. DISCLAIMER: 4DI is a privately developed helping tool. It is not endorsed, certified, or validated by any regulatory authority. Content is for informational purposes only and must not replace official regulatory guidance.

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Version 1.1 Replaced the shield icon on ALCOA++, Regulations, and Glossary pages with a new design that better matches the app logo The shield is now purely decorative and no longer responds to taps Minor UI polish

The developer, Robert Poetzsch, indicated that the app’s privacy practices may include handling of data as described below. For more information, see the developer’s privacy policy .

  • Data Not Collected

    The developer does not collect any data from this app.

    Privacy practices may vary, for example, based on the features you use or your age. Learn More

    The developer has not yet indicated which accessibility features this app supports. Learn More

    • Seller
      • Robert Poetzsch
    • Size
      • 4.8 MB
    • Category
      • Productivity
    • Compatibility
      Requires iOS 18.6 or later.
      • iPhone
        Requires iOS 18.6 or later.
      • Mac
        Requires macOS 15.6 or later and a Mac with Apple M1 chip or later.
      • Apple Vision
        Requires visionOS 2.6 or later.
    • Languages
      • English
    • Age Rating
      4+
    • Copyright
      • © 2026 by Robert Poetzsch