Qualitech Engineering & Compliance

12/12/2025

📄The EU has released an updated draft of GMP Chapter 4 – Documentation, marking the first major revision since 2011.

✅ The new version strengthens expectations around data governance, hybrid systems, electronic signatures, and risk-based documentation management, aligning documentation practices with today’s digital GMP environment.

🔎 We’ve prepared a concise overview highlighting the key updates and their impact on pharmaceutical quality systems.

🎓 Join our Seminar "Key Updates in EU GMP Chapter 4 & Annex 11 Revisions, and the New Annex 22 on Artificial Intelligence", where all recent regulatory updates will be presented and analyzed in depth.

https://qualitechengineering.com/seminar/

19/11/2025

We are excited to announce our upcoming two-day seminar, hosted by Qualitech Engineering & Compliance in collaboration with CONVAL group, dedicated to one of the most significant regulatory updates in recent years:

🔍 Key Updates in EU GMP – Chapter 4, Annex 11, and the New Annex 22 on Artificial Intelligence
📅 15–16 January 2026
📍 Domotel Kastri Athens Hotel – Hall: ATHENA I

The European Medicines Agency (EMA) has recently released major revisions that reshape expectations in documentation practices, computerized systems, data integrity, cybersecurity, and AI governance. This seminar will provide regulatory, technical, and practical insights, helping life sciences professionals prepare for successful implementation.

📘 Agenda Highlights:
Day 1: Documentation principles, digital/hybrid models, data integrity alignment, and industry readiness
Day 2: Annex 11 revisions, operational implementation, Annex 22 AI governance, and panel discussions

👉 Register here: https://lnkd.in/d8ewCedN

04/11/2025

🤖 Artificial Intelligence is no longer the future; it’s already transforming pharmaceutical manufacturing.

💊 The EU’s newly introduced Annex 22 – Artificial Intelligence sets a clear regulatory path for using AI within GMP frameworks.

🔎 At Qualitech, we’ve summarized its key points and practical implications in a concise new overview.

📘 Explore the summary and join us soon for our dedicated seminar on EudraLex - Volume 4: GMP Chapter 4 & Annex 11 Revisions and the New Annex 22 (Artificial Intelligence) Guide, which will take place in Athens on 15–16 January 2026.

22/10/2025

✅ The digital era is reshaping pharmaceutical manufacturing and EU GMP Annex 11 is catching up.

🔎 The upcoming revision introduces a new framework that brings data integrity, QRM, and supplier oversight to the forefront of compliance.

🖥️ At Qualitech, we’ve outlined the key updates that will define the compliance of computerised systems in GxP environments.

📘 Explore our short summary and join us in January 2026 for a dedicated seminar where we’ll go deeper into the practical impacts of these changes.

12/10/2024

Con Qualitech a Bologna

11/10/2024

Να εδώ στο Ίνσμπρουκ

24/04/2024

Best crew ever. Q-Crew on the job. Best colleagues ever. Thodoris Kokkas

Qualitech in action!!! EN285.