# 4DI — Data Integrity Helping Tool

> A professional iOS reference app for pharmaceutical and life science professionals working in GxP-regulated environments.

4DI is a free, fully offline iOS application that covers pharmaceutical data integrity concepts. It is developed by Robert Poetzsch and available on the Apple App Store. The app is available in five languages (English, German, French, Spanish, Italian), collects no user data, and requires no internet connection.

## App Store

- Download: https://apps.apple.com/app/4di-data-integrity-tool/id6760180866
- Price: Free
- Platform: iOS 18.6+
- Current version: 1.5
- Developer: Robert Poetzsch

## Features

### ALCOA++ Principles
Interactive reference for all ten ALCOA++ data integrity principles:
- Attributable: Who performed the action and when?
- Legible: Can the data be read and understood?
- Contemporaneous: Was it recorded at the time it happened?
- Original: Is this the first-captured record?
- Accurate: Is the data correct, truthful, and verified?
- Complete: Is all data present, including metadata?
- Consistent: Does the data tell the same story everywhere?
- Enduring: Will the data last for its required lifetime?
- Available: Can authorized people access it when needed?
- Traceable: "Data should be traceable throughout the data life cycle. Any changes to the data, to the context/metadata should be traceable, should not obscure the original information and should be explained, if necessary." (EMA/INS/GCP/112288/2023, section 4.5)

Each principle includes a definition, real-world practical examples from pharmaceutical environments, correct practices, and common violations.

### Regulatory Frameworks
Summaries and comparison of key data integrity regulations:
- FDA 21 CFR Part 11 — Electronic Records; Electronic Signatures (US, 1997/2003)
- EU GMP Annex 11 — Computerised Systems (EU, 2011)
- MHRA GxP Data Integrity Guidance — Data Integrity Guidance and Definitions (UK/EU, 2018)
- PIC/S PI 041 — Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (International, 2021)
- WHO TRS No. 1033 Annex 4 — Guideline on Data Integrity (International, 2021): https://www.who.int/publications/m/item/annex-4-trs-1033
- EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials (EU, 2023)
- ICH Q7 — Good Manufacturing Practice for Active Pharmaceutical Ingredients

Includes a Key Differences Comparison view highlighting overlaps and divergences across frameworks on audit trails, electronic signatures, and risk-based approaches.

### Data Lifecycle Explorer
Interactive 6-stage walkthrough of data's journey in a GxP environment:
1. Creation — first capture of data (manual entries, instrument readings, electronic acquisition)
2. Processing — transformation, calculation, analysis, data transfers between systems
3. Review & Approval — independent verification, second-person review, formal approval
4. Reporting — compilation into certificates of analysis, regulatory submissions, reports
5. Retention — secure storage during the required retention period
6. Archival & Destruction — long-term preservation or authorized, documented disposal

Each stage maps relevant ALCOA++ principles, identifies common pitfalls, and references applicable regulations.

### Inspection Findings
17 typical data integrity findings based on patterns from public regulatory reports:
- Sources: FDA Warning Letters, FDA 483 observations, EMA GMP non-compliance reports, MHRA Inspectorate findings, PIC/S publications, WHO
- Categories: Electronic Systems, Laboratory Practices, Manufacturing, Quality Oversight, Data Storage
- Each finding includes: severity (Critical/Major), scenario description, affected ALCOA++ principles, regulatory basis, and remediation steps

Example findings: Shared User Accounts, Audit Trail Disabled, System Clocks Not Synchronized, Unvalidated Computerized System, Selective Deletion of Trial Injections, Testing into Compliance, Backdated Batch Records, Inadequate Data Review Process, No Data Integrity Training Program, No Backup for Electronic Data.

### Glossary
Searchable glossary of data integrity terms organized by category:
- ALCOA++ Principles: ALCOA, ALCOA++, Metadata, True Copy, Raw Data
- Regulatory Abbreviations: CFR, GMP, GLP, GDP, GxP, CSV, CSA, ICH, PIC/S, MHRA, FDA, EMA
- Technical Terms: Audit Trail, Electronic Record, Electronic Signature, Hybrid System, Data Lifecycle, Data Governance, Data Integrity, LIMS
- Quality System Terms: CAPA, Deviation, OOS, OOT, Change Control

Features Term of the Day and bookmarking.

## Technical Details

- Language: Swift / SwiftUI
- Persistence: SwiftData (local only)
- Minimum iOS: 18.6
- Network: Fully offline, no internet required
- Data: No collection, no analytics, no tracking, no accounts
- Languages: English, German, French, Spanish and Italian (Spanish and Italian since version 1.5). The website is available in all five languages.
- Theme: Light, Dark, System

## Privacy

4DI does not collect, store, or transmit any personal data to external servers. No analytics services, tracking tools, advertising frameworks, or third-party SDKs are used. All data is stored exclusively on the user's device: glossary bookmarks (SwiftData) and settings (language, appearance, disclaimer acceptance, last "What's New" version; UserDefaults). The app makes no network requests; links to official regulatory sources and to GitHub open in the browser only when tapped. Full privacy policy: https://4di.app.robspace.de/#privacy-policy

## Version History

### V 1.5 (October 2026) — Current: 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 1.4 (September 2026)
- 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 1.3 (March 2026)
- New: Trustworthy principle added as the tenth ALCOA++ principle
- Trustworthy covers system validation, quality culture, data governance, and personnel qualification
- Fully translated into German and French with localized examples
- ALCOA++ tab now displays ten interactive cards

### V 1.2 (March 2026)
- New: Data Lifecycle Explorer with 6 interactive stages
- New: Inspection Findings with 17 categorized findings
- New: 5-tab structure (ALCOA++, Regulations, Lifecycle, Glossary, Findings)
- Removed: GEMBA Walk tool (app refocused as reference/learning tool)

### V 1.1 (March 2026)
- Added first-launch disclaimer screen
- Added Legal Notice section in Settings
- Fixed glossary interaction for German and French
- Simplified GEMBA Walk form
- Added custom checklist management
- Fixed shield icon toolbar tap issue

### V 1.0 (March 2026)
- Initial release
- ALCOA++ Principles with interactive cards
- Regulatory Framework Explorer with comparison view
- GEMBA Walk tool with PDF and Word reporting
- Searchable Glossary with 42+ terms
- Trilingual support (English, German, French)

## Contact

- Email: support@robspace.de
- Developer: Robert Poetzsch
- Address: Brueckenstr. 8A, 65719 Hofheim am Taunus, Germany
- Website: https://4di.app.robspace.de/ (English, German, French, Spanish, Italian: ?lang=en|de|fr|es|it)

## 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 and does not constitute legal, regulatory, or professional advice.