Post by Yxion

𝗜𝘀 𝘆𝗼𝘂𝗿 𝗼𝗿𝗴𝗮𝗻𝗶𝘀𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗲𝗽𝗮𝗿𝗲𝗱 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗿𝗲𝘃𝗶𝘀𝗲𝗱 𝗘𝗨 𝗚𝗠𝗣 𝗔𝗻𝗻𝗲𝘅 𝟭𝟭? 📋 The updated Annex 11 (2026) introduces major changes for regulated organisations. From cybersecurity and AI/ML validation to stricter expectations around audit trails, change control and periodic reviews. To help organisations prepare for these changes, we have fully updated our CSV document framework. Our CSV SOP, templates, operational SOPs and execution forms are aligned with Annex 11:2026, GAMP 5 Second Edition and 21 CFR Part 11. 𝗢𝘂𝗿 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵: ✅ 𝗚𝗮𝗽 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 - identify where your current validation documentation no longer aligns with the revised requirements ✅ 𝗣𝗿𝗶𝗼𝗿𝗶𝘁𝗶𝘀𝗮𝘁𝗶𝗼𝗻 - a practical action plan based on identified gaps ✅ 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 - ready-to-use SOPs and templates, combined with support in setting up or improving your CSV processes Whether you are a start-up building your first QMS or a multinational looking to update existing documentation, we tailor our support to your organisation and level of maturity. Curious where your organisation currently stands? Feel free to contact us for an informal conversation or schedule a gap assessment directly. 📧 [email protected] | 🌐 www.yxion.nl