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📴 Fully Offline🔒 No Data Collection
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.
TrilingualOne-Time AcceptReviewable in Settings
2
ALCOA++ Principles
Explore all ten ALCOA++ 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.
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.
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 11EU GMP Annex 11MHRAPIC/S & WHO
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 StagesALCOA++ MappingPitfallsRegulatory Refs
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 OverviewALCOA++ RelevanceInspector Focus Areas
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+ TermsTerm of the DayBookmarksBy Category
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.
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
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:
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
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.
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.
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About 4DI - Data Integrity Helping Tool
4DI is a free iOS application designed for pharmaceutical and life science professionals working in GxP-regulated environments. The app serves as a comprehensive pocket reference for data integrity concepts, principles, and regulations.
ALCOA++ Principles Covered
The app covers all ten ALCOA++ 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), and Available (can authorized people access it when needed).
Regulatory Frameworks
4DI provides summaries and comparisons of key data integrity regulations: FDA 21 CFR Part 11 covering electronic records and electronic signatures (US), EU GMP Annex 11 covering computerised systems (EU), MHRA GxP Data Integrity Guidance and Definitions (UK/EU), PIC/S PI 041 on good practices for data management and integrity (International), WHO TRS No. 996 Annex 5 on good data and record management practices (International), and ICH Q7 on GMP for active pharmaceutical ingredients.
Data Lifecycle Explorer
An interactive 6-stage walkthrough of data's journey in a GxP environment: Stage 1 Creation, Stage 2 Processing, Stage 3 Review and Approval, Stage 4 Reporting, Stage 5 Retention, Stage 6 Archival and Destruction. Each stage maps relevant ALCOA++ principles, identifies common pitfalls, and references applicable regulations.
Inspection Findings
17 typical data integrity findings based on patterns from FDA Warning Letters, FDA 483 observations, EMA GMP non-compliance reports, MHRA Inspectorate findings, and PIC/S publications. Categories include Electronic Systems, Laboratory Practices, Manufacturing, Quality Oversight, and Data Storage. Each finding includes severity classification (Critical or Major), detailed scenario, regulatory basis, and remediation steps.
Glossary
A searchable glossary of data integrity terms and abbreviations including: ALCOA, ALCOA++, Metadata, True Copy, Raw Data, CFR, GMP, GLP, GDP, GxP, CSV, CSA, ICH, PIC/S, MHRA, FDA, EMA, Audit Trail, Electronic Record, Electronic Signature, Hybrid System, Data Lifecycle, Data Governance, Data Integrity, LIMS, CAPA, Deviation, OOS, OOT, and Change Control.
Technical Specifications
Platform: iOS 17.0 and later. Built with SwiftUI and SwiftData. Languages: English, German, French. Fully offline, no internet connection required. No data collection, no analytics, no tracking, no account required. Free to download from the Apple App Store.
