# 4DI — Data Integrity Tool — ALCOA++ & GxP Compliance Guide

> ALCOA++ & GxP Compliance Guide (iPhone/iPad app by Robert Poetzsch.)

- Source: https://appshunter.io/ios/app/4di-data-integrity-tool/id6760180866 (this page in markdown: same URL + `.md`)
- Developer: [Robert Poetzsch](https://appshunter.io/developer/1860642630)
- Category: Productivity
- Price: Free
- Age rating: 4+
- Requires: iOS 18.6 · 4 MB
- Languages: American English
- Released: 2026-03-11
- Data updated: 2026-08-30
- User reviews in markdown: https://appshunter.io/ios/app/4di-data-integrity-tool/id6760180866/reviews.md

## What is 4DI?

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.


## Version history (last 4 releases)

### 1.3 — 2026-03-19

Added the "Trustworthy" principle to the ALCOA++ tab, completing the full set of 10 ALCOA++ principles.

Includes detailed definition, 3 practical examples with correct practices and common violations, covering system validation, quality culture, and personnel qualification.

Fully available in English, German, and French.

### 1.2 — 2026-03-16

NEW: Data Lifecycle Explorer
Follow data's complete journey through a GxP environment -- from creation to destruction. An interactive visual timeline guides you through all six lifecycle stages: Creation, Processing, Review and Approval, Reporting, Retention, and Archival/Destruction. Each stage shows which ALCOA++ principles matter most at that phase, common pitfalls to avoid, relevant regulatory references, and actionable best practices. Fully trilingual (EN/DE/FR).
 
NEW: Common Findings Explorer
A categorized, searchable collection of 17 typical data integrity inspection findings -- the kind of things FDA Warning Letters and EU GMP non-compliances flag. Each finding includes a detailed description of what went wrong, which ALCOA++ principles were violated and why, the regulatory basis citing specific frameworks, and step-by-step recommended remediation. Findings are organized into five categories: Electronic Systems, Laboratory Practices, Manufacturing Documentation, Quality Oversight, and Data Storage. Includes links to official regulatory databases (FDA Warning Letters, EMA GMP reports, MHRA Inspectorate, PIC/S, WHO). Fully trilingual (EN/DE/FR).
 
REMOVED: GEMBA Walk
The GEMBA Walk documentation tool has been removed in this version. Camera and photo library permissions are no longer required.
 
The app now features five tabs: ALCOA++ Principles, Regulatory Frameworks, Data Lifecycle Explorer, Glossary, and Common Findings.

### 1.1 — 2026-03-11

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

### 1.0 — 2026-03-11

No release notes.

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All apps by Robert Poetzsch: https://appshunter.io/developer/1860642630

## Related topics

[data integrity guidance](https://appshunter.io/ios/topics/data-integrity-guidance) · [integrity index](https://appshunter.io/ios/topics/integrity-index)

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*Data collected daily from the US App Store and indexed by [AppsHunter](https://appshunter.io/). User reviews are verbatim App Store reviews. Ratings, prices and chart positions refresh continuously; this snapshot is from 2026-08-30.*