ECA调查：2026年设备确认中AI使用情况调查结果（114名参与者）

Currently, one of the 'hottest topics' in the GMP environment is the use of Artificial Intelligence (AI). Is it also possible to use AI in the field of equipment qualification? We already surveyed this in 2024. Now two years have passed. What has changed? What is the current view of the use of AI today? 114 participants took part in the survey this time. Not every participant answered every single question, and multiple answers were possible in some of the questions. Rounding also means that the totals do not always add up to 100%. The results are presented below. The majority of the 114 participants came from the pharmaceutical industry or from active pharmaceutical ingredient (API) manufacturers (46%), and 20% of participants work in engineering/consultancy. 13% of participants work with biologics. 55% of respondents came from companies with more than 500 employees. The remainder is divided as follows: participants from companies with 101-500 employees (18%), 12% from companies with 51-100 employees and 16% from companies with 1-50 employees.The first question on AI aimed to establish what participants' previous AI training looked like. The majority (40%) had more than 20 hours of training, 24% had 5-20 hours and 36% had 1-5 hours. The next question targeted the use of AI directly within equipment qualification: how often do you use AI during equipment qualification activities? Here, 46% stated that they do not use AI. However, 22% of participants reported daily use. Other responses were once a week (18%) or once a day (14%). In 2024, 83% of participants generally did not use AI in the GMP environment. And in which areas is AI used? The largest group was 'other', which is discussed in more detail below. 25% of responses related to writing risk assessments, 15% use AI to analyse data, 9% to write qualification reports and 7% to write qualification protocols. 5% use AI to write user requirements. And what falls under 'Other'? The responses were very varied. The most frequently mentioned were all of the above-mentioned activities (9%)and research on regulatory requirements and guidelines (7%)The next question (multiple answers possible) concerned how equipment qualification is generally carried out. 48% of participants stated that they do this purely on paper, 26% use software-based tools and 52% work in a 'hybrid' way. Just 9% reported using AI tools. In 2024, over 60% still worked purely on paper, and software use stood at 9% at that time.And what does the outlook for the future look like? We asked participants what they expect. The responses could be grouped into four categories: 'strongly disagree', 'disagree', 'agree' and 'fully agree'. Because multiple answers could be selected, a somewhat mixed picture emerges in each case. However, some answers are fairly clear. Asked whether AI will have disappeared again in a few years' time, 58% answered 'strongly disagree'. The answers to the question of whether AI will take over most GxP activities, except for release, were also interesting. Here the answers were almost evenly split at 50:50, with 45% disagreeing and 40% agreeing. Yet despite AI, expert training retains a high value: 57% of participants do not believe that AI will replace expert knowledge. And 60% agreed with the statement that guidelines will become even more important. High agreement (51%) was also received for the question of whether the quality of qualification activities will increase through AI because human errors are eliminated.Conclusion: The use of AI within equipment qualification is still cautious, but higher than in the 2024 survey. Those who do use it, however, do so very extensively. Equipment qualification is still heavily paper-based, but the use of software-based tools has increased markedly since 2024. Are you interested in this topic? The ECA is running an online training course on 'AI & Digitalisation in Qualification and Validation' on 17/18 November 2026.