First Questionnaire
DraftQuestions
1
Gibt es eine URS und ist diese aktuell und entsprechend Intended Use?
Document: Annex 11 Draft
Section: 2.5
Chapter: Principles
Low
Artificial Intelligence Validation Owner
Content Management Owner
Data Governance Owner
System Owner
2
Werden Alarme visuell / akustisch der Arbeitsumgebung angemessen signalisiert?
Document: Annex 11 Draft
Section: 8.3
Chapter: Alarms
Low
Artificial Intelligence Validation Owner
Content Management Owner
Data Governance Owner
System Owner
3
Können kritische Alarme (betreffend product quality, patient safety or data integrity) nur von Berechtigten mit Kommentar (Begründung) quittiert werden?
Document: Annex 11 Draft
Section: 8.4
Chapter: Alarms
High
Artificial Intelligence Validation Owner
Content Management Owner
Data Governance Owner
System Owner
Distributions
| System | Distributed | Deadline | Progress | |
|---|---|---|---|---|
| Aufderhar, Franecki and Kling — Information Technology | 26.03.2026 | 27.03.2026 | 0 / 5 submitted | View Responses |
| Kub-Crooks — Information Technology | 26.03.2026 | 31.03.2026 | 1 / 5 submitted | View Responses |
| Johns-Schamberger — Human Resources | 26.03.2026 | 30.03.2026 | 1 / 5 submitted | View Responses |
| Borer, Kirlin and Hoppe — Finance & Accounting | 26.03.2026 | 31.03.2026 | 0 / 5 submitted | View Responses |
| Borer, Kirlin and Hoppe — Finance & Accounting | 26.03.2026 | 31.03.2026 | 0 / 1 submitted | View Responses |
| Borer, Kirlin and Hoppe — Finance & Accounting | 26.03.2026 | 28.03.2026 | 0 / 1 submitted | View Responses |