4DI

4DI — Data Integrity Helping Tool

Your pocket reference for pharmaceutical data integrity.

A professional helping tool designed for pharmaceutical and life science professionals. Covers ALCOA++ principles, regulatory frameworks, the complete data lifecycle, real-world inspection findings, and a comprehensive glossary — all in one app.

🇬🇧 English 🇩🇪 Deutsch 🇫🇷 Français 🇪🇸 Españolfrom version 1.5 🇮🇹 Italianofrom version 1.5 📴 Fully Offline 🔒 No Data Collection
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A Guided Tour Through 4DI

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

1

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. New installations start in your iPhone’s language if it is English, German, French, Spanish or Italian, otherwise in English.from version 1.5

Multilingual One-Time Accept Reviewable in Settings
Disclaimer Screen
2

ALCOA++ Principles

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

10 Principles Interactive Cards Tappable Details incl. Traceable
ALCOA++ Principles
3

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
Principle Detail View
4

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 EMA (2023) MHRA PIC/S & WHO
Regulatory Frameworks
5

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
Data Lifecycle Explorer
6

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
Lifecycle Stage Detail
7

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
Glossary
8

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
Inspection Findings
9

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. Your selection stays when you fold or unfold.from version 1.6

Half Open Open Like a Book Selection Kept
iPhone Duo half open

Release Notes

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

V 1.6October 2026
iPhone Duo
  • 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.
V 1.5October 2026
Spanish and Italian
  • 4DI now also speaks Spanish and Italian, in addition to English, German and French.
  • 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.
  • Your bookmarks and settings stay as they are.
V 1.4September 2026
Traceable, Current WHO and EMA Guidance
  • ALCOA++ updated: the tenth principle is now "Traceable" (EN/DE/FR), following the EMA guideline on computerised systems and electronic data in clinical trials (2023) and the draft revision of EU GMP Chapter 4 (2025) — with a new definition, practical examples, and links in the data lifecycle and inspection findings. It replaces "Trustworthy", which is not an attribute in any official source.
  • New framework: the EMA guideline on computerised systems (2023), including comparison entries.
  • WHO references updated to the current WHO data integrity guideline TRS 1033 Annex 4 (2021), which replaces TRS 996 Annex 5.
  • Glossary complete in all three languages with correct German and French spelling; search also finds terms typed without accents.
  • A short "What's New" screen appears once after each update.
  • Built for iOS 27; new "Community & Feedback" section in Settings (EN/DE/FR).
  • Bookmarks, language and appearance settings carry over unchanged.
V 1.3March 2026
New Principle & Content Update
  • New ALCOA++ principle: Trustworthy — added as the tenth principle covering system validation, quality culture, data governance, and personnel qualification. Includes full definition, three practical examples with correct practices and common violations.
  • Trustworthy principle is fully translated into German ("Vertrauenswuerdig") and French ("Fiable") with localized examples and definitions.
  • ALCOA++ Principles tab now displays ten interactive cards instead of nine.
  • New principle color and icon (lock.shield.fill) integrated into the existing design system.
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 ten ALCOA++ 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 · Last updated: October 14, 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.

Controller within the meaning of the GDPR is Robert Poetzsch, email support@robspace.de. The postal address is in the Impressum (legal notice) on this website.

Data Collection

4DI does not collect, store, or transmit any personal data to external servers. The App's content works entirely offline; none of its features requires an internet connection. The App itself makes no network requests. Only if you tap one of the external links described under “Links” below does your browser load the linked page.

Data Stored on Your Device

The App stores the following data locally on your device:

This data is stored exclusively on your device and is never transmitted to the Developer or any third party. It can be included in your device's backup through Apple (iCloud or computer) if you use it.

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.

Links

The App contains links to external websites: the official sources of the regulatory frameworks and the official databases in the Findings tab (for example fda.gov, ema.europa.eu, gov.uk, picscheme.org, who.int, ich.org), and, in the “Community & Feedback” section of Settings, pages on github.com. A link opens only when you tap it, in your browser. The App itself does not send any data in the process. The website you open receives the usual connection data (such as your IP address); its operator's privacy policy applies.

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

You can remove a bookmark at any time by tapping its bookmark icon in the Glossary again, and change your language and theme in the App's Settings. Deleting the App from your device removes all data stored by the App.

This Website

This website is hosted by Hetzner Online GmbH on a server in a data centre in Falkenstein, Germany. When you open a page, the web server automatically logs your IP address, the date and time, the requested page or file, the HTTP status, the number of bytes transferred, the referring page (referrer) and your browser’s user agent. These logs are used solely to operate and secure the website; the legal basis is Art. 6(1)(f) GDPR (legitimate interest in secure, stable operation). They are deleted automatically after 14 days at the latest, are not analysed and are not passed on unless required by law.

The website sets no cookies, uses no analytics or tracking and embeds no content from third parties. Only your language choice and, in the web app, your bookmarks, theme and the confirmation of the disclaimer are kept in your browser’s local storage; they stay in your browser and are not used for tracking. Fonts are served from this server; no connection is made to Google Fonts or other font services.

Your Rights

You have the right of access, rectification, erasure, restriction of processing, data portability and objection (Art. 15–21 GDPR). Because the App does not send us any data about you, there is nothing we could disclose, correct or delete; questions are still welcome at support@robspace.de. You have the right to lodge a complaint with a data protection supervisory authority, for example the Hessian Commissioner for Data Protection and Freedom of Information (HBDI).

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 date.

Contact

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

Impressum

Information according to § 5 DDG (German Digital Services Act)

Developer

Robert Poetzsch
Brückenstr. 8A
65719 Hofheim am Taunus
Germany

Contact

Email: support@robspace.de

Responsible for Content pursuant to § 18 para. 2 MStV

Robert Poetzsch (address as above)

EU Digital Services Act (DSA) — Trader Status Declaration

In accordance with Article 30 of Regulation (EU) 2022/2065 (Digital Services Act), we declare that we act as a trader within the meaning of EU consumer protection law when offering 4DI through the Apple App Store.

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. The fonts used on this website (DM Sans, Outfit, JetBrains Mono) are licensed under the SIL Open Font License 1.1 and are served from this website.

Important Disclaimer: 4DI is a privately developed helping tool. It 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. The content is intended for informational purposes only.