4DI — Data Integrity Tool

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. 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: [email protected]. 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.