
4DI — Data Integrity Tool
ALCOA++ & GxP Compliance Guide
0 ratings
Free
About
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.
Show more
What's New in 4DI
1.3
March 19, 2026
Added the "Trustworthy" principle to the ALCOA++ tab, completing the full set of 10 ALCOA++ principles. Includes detailed definition, 3 practical examples with correct practices and common violations, covering system validation, quality culture, and personnel qualification. Fully available in English, German, and French.
More






