4DI — Data Integrity Tool

GxP Data Integrity Reference

Only for iPhone

Free · Designed for iPhone. Not verified for macOS.

iPhone

Now in five languages. An offline ALCOA++ and GxP reference for QA and validation — principles, regulations, lifecycle, inspection findings and a glossary. 4DI is an offline reference tool for data integrity in regulated environments — built for QA, validation, manufacturing, and laboratory teams working under GxP. The app organizes data integrity knowledge into five areas: ALCOA++ principles, regulatory frameworks, the data lifecycle, typical inspection findings, and a glossary. ALCOA++ PRINCIPLES 10 principles, each with a clear definition and practical examples contrasting good practice with a typical violation: - Attributable - Legible - Contemporaneous - Original - Accurate - Complete - Consistent - Enduring - Available - Traceable (added per the EMA guideline on computerised systems and electronic data in clinical trials, 2023) REGULATORY FRAMEWORKS 7 frameworks side by side, each with a summary, core requirements, and a link to the official source: - FDA 21 CFR Part 11 - EU GMP Annex 11 - MHRA GxP Data Integrity Guidance - EMA Guideline on computerised systems and electronic data in clinical trials (2023) - PIC/S PI 041 - WHO TRS 1033, Annex 4 — Guideline on data integrity (2021) - ICH Q7 Frameworks are tagged by region (US / EU / International). A comparison view highlights key differences across four topics: audit trail, electronic signatures, risk-based approach, and quality culture & human factors. DATA LIFECYCLE Six phases — Creation, Processing, Review & Approval, Reporting, Retention, Archival & Destruction — each mapped to its relevant ALCOA++ principles, typical pitfalls, and regulatory focus. INSPECTION FINDINGS 17 findings modeled on public patterns from FDA Warning Letters, Form 483 observations, and EU GMP non-conformities. Organized by category and severity, each finding lists the principles violated, its regulatory basis, and remediation measures, with links to official databases. Full search included. GLOSSARY 29 terms — ALCOA terms, regulatory abbreviations (CFR, GMP, GLP, GCP...), technical terms (audit trail, metadata, electronic signature), and quality terms (CAPA, deviation, OOS) — each with a definition and context. Bookmark terms for quick access, get a "term of the day," and search even without typing accents. FIVE LANGUAGES 4DI speaks English, German, French, Spanish and Italian. A new installation starts in your iPhone's language when 4DI supports it. You can switch the language any time in the app's Settings. MADE FOR IPHONE DUO Half open, one half holds the definition or finding you picked while the other lets you browse and compare; fully open, list and details sit side by side like a book. BUILT FOR OFFLINE USE Light, dark, or system appearance. Works entirely offline: no accounts, no tracking, no ads, no permissions required. Bookmarks stay on your device. COMMUNITY & SUPPORT Report a bug, suggest a feature, or flag a content correction through the app's Settings — linked to robspace's public GitHub hub for discussion. For direct support: support@robspace.de. 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 or professional advice.

  • This app hasn’t received enough ratings or reviews to display an overview.

4DI 1.6 • Made for iPhone Duo: half open, one half holds the definition or finding you picked, the other lets you browse and compare. • Fully open, the list and its details sit side by side like a book. Your selection and scroll position stay when you fold or unfold. Your bookmarks and settings stay as they are.

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
    5.6 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 and 4 more
    • English, French, German, Italian, Spanish
    Age Rating
    4+
    Copyright
    © 2026 by Robert Poetzsch