4DI is a professional helping tool built for pharmaceutical and life science professionals who work in GxP-regulated environments
4DI is a professional helping tool built for pharmaceutical and life science professionals who work in GxP-regulated environments. Whether you are a quality manager, lab technician, validation specialist, or data integrity officer - 4DI puts essential data integrity knowledge and practical tools right in your pocket. 4DI bridges the gap between regulatory theory and everyday practice on the shop floor. ALCOA++ PRINCIPLES Explore all nine ALCOA++ data integrity principles through interactive, beautifully designed cards. Each principle includes a clear definition, real-world pharmaceutical examples showing both correct practices and common violations, and practical guidance you can apply immediately. Test your knowledge with a built-in quiz featuring 20+ questions. Track your scores over time and watch your expertise grow. REGULATORY FRAMEWORK EXPLORER Navigate the key regulatory frameworks that govern data integrity in pharma: - FDA 21 CFR Part 11 - EU GMP Annex 11 - MHRA GxP Data Integrity Guidance - PIC/S PI 041 - WHO Technical Report Series No. 996, Annex 5 - ICH Q7 Compare frameworks side-by-side to understand where they overlap and differ on critical topics like audit trails, electronic signatures, and risk-based approaches. Color-coded regional tags make orientation effortless. GEMBA WALK DOCUMENTATION Document data integrity observations directly on the production floor. The structured GEMBA Walk tool lets you: - Record observations with location, area, and detailed notes - Attach photos as supporting evidence - Use customizable checklists tailored to your site - Generate professional PDF and Word reports ready for your quality management system - All reports include confidentiality notices and professional formatting COMPREHENSIVE GLOSSARY Access 40+ data integrity terms and abbreviations covering ALCOA++ terminology, regulatory abbreviations (CFR, GMP, GLP, CSV, CSA), technical terms (audit trail, metadata, electronic signature), and quality system terms (CAPA, deviation, OOS, OOT). Each entry includes the full expansion, a clear definition, and context of use. Bookmark your most-used terms and discover something new every day with the Term of the Day feature. DESIGNED FOR PROFESSIONALS - Trilingual: Full support for English, German, and French - Dark and Light mode for comfortable use in any environment - Offline-first: All content available without an internet connection - Privacy-focused: All data stays on your device - No account required, no tracking, no ads 4DI is your daily companion for data integrity excellence in regulated environments. DISCLAIMER: 4DI is a privately developed helping tool. It is not endorsed, certified, or validated by any regulatory authority. Content is for informational purposes only and must not replace official regulatory guidance.
| # | Name | Price | Currency | Region |
|---|---|---|---|---|
| 1 | Item | ¥ 0 | CNY | 中国 |
