ECA验证组2026年5-8月更新:良好实践指南资格与验证v3.0全面审查及AI附录草案
Validation Group Update May-August 2026
ECA正在对《良好实践指南:确认与验证》第3.0版及其附录进行全面审查,同时一份ECA手册第二稿和一份新手册草案待定稿。新设的人工智能确认子组已起草关于AI用于确认与验证的附录,一项关于AI用于设备确认的调查已完成评估。AI确认与验证课程将于2026年11月17/18日以线上形式开课。
Guideline DevelopmentsCurrently there is a complete review of ECA`s Good Practice Guide Qualification and Validation including the annexes, version 3.0. A second draft of an ECA booklet is available and will be finalised. A new booklet is available as a draft version and will be finalised. A new subgroup about Artificial Intelligence in Qualification has drafted an annex about AI used in Qualification and Validation. Surveys A survey about the use of Artificial Intelligence in equipment qualification has been evaluated. Miscellaneous An AI in Qualification and Validation course has been developed and will be offered on 17/18 November 2026 as an online course. The ECA Foundation maintains a total of 10 Interest Groups. You can find out more about these groups and their developments on the ECA Foundation website. And if you are not yet a member of the Validation Group, simply sign up for membership here. Membership is free of charge.
来源:ECA GMP News · gmp-compliance.org