AI Governance is the overall set of organizational structures, policies, processes and rulesets that ensure the responsible and effective use of AI within an organization. It covers roles and responsibilities, decision-making functions and bodies, a use-case register with risk classification,…
The AI model is the AI itself within the AI system – the trained component that derives outputs from inputs. The EU AI Act defines the AI system (Art. 3 No. 1) and – for general-purpose models only – the…
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An AI system is a machine-based system that is designed to operate with varying levels of autonomy, that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers from the input it receives how to generate outputs…
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ALCOA is a common acronym summarizing the criteria of data integrity (the ALCOA principles). It stands for:
Attributable (i.e., identification of the source, the data originator – person, device, or system)
Legible (and understandable)
Contemporaneous (i.e., recorded at the time)…
An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled.…
An audit trail is the secure, computer-generated, time-stamped record of relevant creations, changes, and deletions of GxP-relevant data – who, what, when, and why; which events it captures is defined on a risk basis (EU GMP Annex 11 §9; 21…
