Practitioner articles
Detailed explanations, worked reasoning, and practical guidance for software validation and assurance decisions.
22 resources in AI Assurance
AI Assurance
A field-ready method for deciding whether an AI-enabled GxP workflow is fit for release—without mistaking model accuracy, vendor claims, or human review for a complete validation rationale.
AI Assurance
An assistant produces a list of protocol findings in seconds. The reviewer finishes faster. That looks promising, but time alone does not establish whether the review improved.
Foundation · Video and chapter
Identify everything that can influence the AI-assisted outcome. A model is one component. A different document parser can drop a table; a retrieval filter can select an obsolete procedure; a reviewer can accept an unsupported answer; an integration can save it to the wrong record.
Foundation · Video and chapter
A predictive model estimates a value or category. A generative model produces content. A RAG application supplies retrieved material to support generation. An agent can select or execute actions through tools. These descriptions can overlap within one application.
Foundation · Video and chapter
“Helps Quality” is too broad. State what the assistant does, with which information, for which users, before which decision, and with which limits. Context includes the user’s expertise, workload, available sources, and consequences of an incorrect answer.
Foundation · Video and chapter
GxP is shorthand for several regulated good-practice areas. Determine the applicable process and obligations rather than treating GxP as a single global rulebook.
Practitioner · Video and chapter
Someone must own the use, technical service, quality decision, information protection, monitoring, and incident response. One person may hold several responsibilities, but gaps should not be hidden behind a general “AI team” label.
Practitioner · Video and chapter
“Hallucination risk” is too general to design an adequate test. Identify the unsupported statement, the use of that statement, and what could happen next.
Practitioner · Video and chapter
An evidence plan connects a claim to a test, review, analysis, or operational control. Avoid collecting only evidence that the application runs or that users like it.