# 4DI — Data Integrity Helping Tool > Free iPhone app for pharmaceutical data integrity: ALCOA++ principles, FDA, EU GMP, MHRA and PIC/S rules, data lifecycle, inspection findings and a glossary. Full English text of https://4di.app.robspace.de/ as Markdown, generated from the page (last updated 2026-10-28). Other languages: Deutsch: https://4di.app.robspace.de/de/, Français: https://4di.app.robspace.de/fr/, Español: https://4di.app.robspace.de/es/, Italiano: https://4di.app.robspace.de/it/. Short overview: https://4di.app.robspace.de/llms.txt 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 🇪🇸 Español (from version 1.5) 🇮🇹 Italiano (from version 1.5) 📴 Fully Offline 🔒 No Data Collection [an app by robspace](https://robspace.de) [Download on the App Store](https://apps.apple.com/app/4di-data-integrity-tool/id6760180866) [Try it in your Browser](https://4di.app.robspace.de/webapp/) Coming Soon on Google Play Help shape 4DI [Report a bug](https://github.com/RobEarth0815/robspace-apps/issues/new?labels=app%3A4di%2Ctype%3Abug%2Cstatus%3Aneeds-triage&template=bug_report.yml) [Suggest a feature](https://github.com/RobEarth0815/robspace-apps/issues/new?labels=app%3A4di%2Ctype%3Aenhancement%2Cstatus%3Aneeds-triage&template=feature_request.yml) [Discuss](https://github.com/RobEarth0815/robspace-apps/discussions) ## 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. 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 ### 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 ### 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 EMA (2023) 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 ### 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 ## Release Notes What's new and improved in each version of 4DI. V 1.6 October 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 1.5 October 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 1.4 September 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](https://www.who.int/publications/m/item/annex-4-trs-1033) (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 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 1.2 March 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 1.1 March 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 1.0 March 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](https://4di.app.robspace.de/#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: - Glossary bookmarks (which terms you bookmarked and when), in the App's local database (Apple's SwiftData framework) - App settings (language preference, theme selection), in the App's local settings storage (UserDefaults); on first launch the App reads your device's system language once to preselect the App language, locally only and without transmitting it - Disclaimer acceptance status, also in UserDefaults - The App version for which the “What's New” screen was last shown, also in UserDefaults 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](mailto: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](mailto: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. ## 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), Available (can authorized people access it when needed), and 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). ### 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. 1033 Annex 4](https://www.who.int/publications/m/item/annex-4-trs-1033) Guideline on Data Integrity, 2021 (International), the EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials, 2023 (EU), 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, GCP, GxP, CSV, ICH, PIC/S, MHRA, FDA, Audit Trail, Electronic Signature, Hybrid System, Data Lifecycle, Data Integrity, LIMS, CDS, Backup, CAPA, Deviation, OOS, SOP, Warning Letter, and Form 483. ### Technical Specifications Platform: iOS 18.6 and later. Layouts for iPhone Duo from version 1.6. Built with SwiftUI and SwiftData. Languages: English, German, French; Spanish and Italian from version 1.5. Fully offline, no internet connection required. No data collection, no analytics, no tracking, no account required. Free to download from the Apple App Store. ## Frequently asked questions ### What is ALCOA++ in pharmaceutical data integrity? ALCOA++ is a framework of ten principles for data integrity in GxP-regulated environments: Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA), plus Complete, Consistent, Enduring, Available, and Traceable (the ++ additions). These principles are referenced by FDA, EMA, MHRA, PIC/S, and WHO guidance documents. ### Which regulatory frameworks cover pharmaceutical data integrity? Key frameworks include FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures), EU GMP Annex 11 (Computerised Systems), MHRA GxP Data Integrity Guidance (2018), PIC/S PI 041 (Good Practices for Data Management and Integrity), WHO TRS No. 1033 Annex 4 (Guideline on Data Integrity, 2021), the EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials (2023), and ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients). ### What are common data integrity inspection findings? Common findings include shared user accounts, disabled audit trails, unsynchronized system clocks, unvalidated computerized systems, selective deletion of trial injections, testing into compliance, backdated batch records, blank fields in records, use of correction fluid, inadequate data review processes, and lack of data integrity training programs. ### What is the data lifecycle in a GxP environment? The data lifecycle in a GxP environment consists of six stages: Creation (first capture of data), Processing (transformation and analysis), Review and Approval (independent verification), Reporting (compilation into formal documents), Retention (secure storage during required period), and Archival/Destruction (long-term preservation or authorized disposal). Data integrity must be maintained throughout all stages. ### Does the 4DI app collect personal data? No. 4DI operates fully offline, does not connect to any server, does not require an account, and does not collect, transmit, or store any personal data externally. All app data is stored locally on the user's device.