4DI — Data Integrity Helping Tool

A Guided Tour Through 4DI

From first launch to deep regulatory knowledge — here is how 4DI works.

Clear Legal Disclaimer

On first launch, 4DI presents a transparent disclaimer in your chosen language. The app clearly states that it is an independent helping tool — not endorsed by any regulatory authority. Accept once and you are ready to go.

Trilingual One-Time Accept Reviewable in Settings

$Disclaimer Screen$

ALCOA++ Principles

Explore all nine data integrity principles through interactive, color-coded cards. Each principle — from Attributable to Available — is presented with a clear icon and guiding question to help you understand its purpose at a glance.

9 Principles Interactive Cards Tappable Details

In-Depth Principle Details

Tap any principle to reveal its full definition, real-world practical examples from pharmaceutical environments, correct practices, and common violations to avoid. Everything you need for training sessions or quick reference during an audit.

Correct Practices Common Violations Real-World Examples

Regulatory Frameworks

Navigate the global regulatory landscape with summaries of key data integrity frameworks. Each framework is color-coded by region and shows the issuing authority, version, and key requirements. A dedicated comparison view highlights overlaps and differences.

FDA 21 CFR Part 11 EU GMP Annex 11 MHRA PIC/S & WHO

Data Lifecycle Explorer

Follow data on its complete journey in a GxP environment — from creation through processing, review, reporting, retention, all the way to archival and destruction. Each of the six stages maps relevant ALCOA++ principles, common pitfalls, and regulatory references.

6 Stages ALCOA++ Mapping Pitfalls Regulatory Refs

Deep Dive Into Each Stage

Tap any lifecycle stage to explore it in depth. See exactly which ALCOA++ principles matter most at that stage, understand the specific pitfalls inspectors look for, and review the regulatory basis from FDA, EU GMP, and international guidelines.

Stage Overview ALCOA++ Relevance Inspector Focus Areas

Searchable Glossary

Look up any data integrity term instantly. The glossary is organized by category, searchable, and features a daily Term of the Day to keep your knowledge fresh. Bookmark your most-used terms for quick access.

29+ Terms Term of the Day Bookmarks By Category

Inspection Findings

Learn from real-world mistakes. Browse 17 typical data integrity findings from FDA Warning Letters and EU GMP inspections, categorized by area and severity. Each finding includes a detailed scenario, regulatory basis, and concrete remediation steps.

Critical Findings Major Findings Electronic Systems Laboratory Practices

Release Notes

What's new and improved in each version of 4DI.

V 1.2March 2026

New Features & Major Update

New tab: Data Lifecycle Explorer — an interactive 6-stage walkthrough covering Creation, Processing, Review & Approval, Reporting, Retention, and Archival/Destruction. Each stage maps relevant ALCOA++ principles, common pitfalls, and regulatory references.
New tab: Inspection Findings — 17 typical data integrity findings from FDA Warning Letters and EU GMP inspections. Each finding includes scenario description, severity classification, affected ALCOA++ principles, regulatory basis, and remediation steps.
Inspection Findings are categorized by area: Electronic Systems, Laboratory Practices, Manufacturing, Quality Oversight, and Data Storage. Searchable and filterable by category.
Added link to official regulatory databases for direct access to source documents.
App now features 5 tabs: ALCOA++, Regulations, Lifecycle, Glossary, and Findings.
Removed GEMBA Walk tool and custom checklists to focus the app on its core strength as a reference and learning tool.
Camera and Photo Library permissions are no longer required.
Updated glossary content and term count.

V 1.1March 2026

Bug Fixes & Improvements

Fixed decorative shield icon in the navigation bar toolbar appearing as a tappable button across multiple tabs.
Added first-launch disclaimer screen that must be accepted before using the app.
Added Legal Notice section in Settings for reviewing the disclaimer at any time.
Fixed glossary term interaction for German and French languages — tapping terms with longer translated names now works reliably.
Simplified GEMBA Walk form with streamlined workflow.
Added custom checklist management for GEMBA Walks.
Photos now embedded in Word report exports as inline images.
Added developer and copyright information in Settings.

V 1.0March 2026

Initial Release

ALCOA++ Principles — all nine data integrity principles with interactive cards, definitions, practical examples, correct practices, and common violations.
Regulatory Framework Explorer — FDA 21 CFR Part 11, EU GMP Annex 11, MHRA, PIC/S PI 041, WHO TRS 996, and ICH Q7 with Key Differences Comparison view.
GEMBA Walk Tool — structured observation forms, photo attachments, PDF and Word report generation.
Searchable Glossary — 42+ terms organized by category with bookmarking and Term of the Day.
Full trilingual support for English, German, and French.
Light, Dark, and System theme modes.
Settings with app information, language selection, and theme switching.
Built with SwiftUI and SwiftData. Fully offline, all data on device.

Your Data Stays Yours

4DI does not collect, transmit, or store any personal data on external servers. All information is stored exclusively on your device.

🔒 No Data Collection

📴 Fully Offline

🚫 No Analytics

👤 No Account Required

Privacy Policy

Effective date: March 1, 2026

Robert Poetzsch ("Developer", "we", "us") operates the 4DI mobile application ("the App"). This Privacy Policy explains how we handle information in connection with the App.

Data Collection

4DI does not collect, store, or transmit any personal data to external servers. The App operates entirely offline and does not require an internet connection for any of its features.

Data Stored on Your Device

The App stores the following data locally on your device using Apple's SwiftData framework:

Glossary bookmarks and preferences
App settings (language preference, theme selection)
Disclaimer acceptance status

This data is stored exclusively on your device and is never transmitted to the Developer or any third party.

Analytics and Tracking

4DI does not use any analytics services, tracking tools, advertising frameworks, or third-party SDKs. No usage data, crash reports, or behavioral information is collected or shared.

Third-Party Services

4DI does not integrate with any third-party services, APIs, or cloud platforms. There is no server-side component.

Children's Privacy

The App is not directed at children under the age of 13. We do not knowingly collect any information from children.

Data Deletion

All data stored by the App can be deleted by the user at any time through the App's Settings or by deleting the App from the device.

Changes to This Privacy Policy

We may update this Privacy Policy from time to time. Any changes will be reflected on this page with an updated effective date.

Contact

If you have any questions about this Privacy Policy, please contact us at support@robspace.de.

Impressum

Information according to § 5 TMG (German Telemedia Act)

Developer

Robert Poetzsch
Brückenstr. 8A
65719 Hofheim am Taunus
Germany

Contact

Email: support@robspace.de

Responsible for Content

Robert Poetzsch (address as above)

Disclaimer

4DI is a privately developed helping tool for data integrity concepts in pharmaceutical and regulated environments. This app is NOT an official regulatory tool and is NOT endorsed, certified, or validated by any regulatory authority including the FDA, EMA, MHRA, WHO, PIC/S, ICH, or any other government or industry body.

While every effort has been made to ensure the accuracy of the content, no legal guarantee, warranty, or assurance of correctness is provided for any information contained in this app — including ALCOA++ definitions, regulatory framework summaries, and glossary definitions.

The content is intended for informational purposes only and does not constitute legal, regulatory, or professional advice. Users should always consult official regulatory documents and qualified professionals for compliance decisions.

Liability for Links

This website and the App may contain links to external websites. We have no influence on the content of these external sites and therefore accept no liability for them. The respective provider or operator of linked pages is always responsible for their content.

Copyright

© 2026 Robert Poetzsch. All rights reserved. The content and design of this website and the 4DI application are protected by copyright. Any reproduction, processing, distribution, or use beyond the scope of copyright law requires the written consent of the developer.