Practitioner library

Insights

Deep, decision-focused material for the assurance problems that do not fit a generic checklist.

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23 resources in All

01

Foundation · Published

From Deterministic Validation to AI Assurance

AI changes the assurance problem because correct behavior can no longer be reduced to “the same input always produces the same output.” A professional CSA strategy therefore validates the complete sociotechnical system: intended use, data, model, application logic, human decisions, operating controls, and evidence over time.

Objective-led chapter6 min
02

Foundation · Published

Classifying AI Systems and Drawing the Boundary

An AI assurance strategy fails early when the team treats “the model” as the system. This chapter provides a practical taxonomy and boundary method for predictive models, computer vision, generative AI, retrieval-augmented generation, embedded vendor features, and agents.

Objective-led chapter6 min
03

Foundation · Published

Intended Use and Context of Use

The intended-use statement is the anchor for AI requirements, risk, data, evaluation, human oversight, monitoring, and change control. This chapter shows how to write one that is precise enough to validate.

Objective-led chapter6 min
04

Foundation · Published

GxP Applicability and Risk-Based Scoping

Professional AI assurance starts by identifying the governing process and record—not by declaring that every AI tool is GxP or that every assistant is merely “productivity software.” This chapter provides a feature-level scoping method.

Objective-led chapter6 min
05

Practitioner · Published

Governance, Accountability, and the AI Inventory

AI governance becomes operational only when every production use has an owner, an identifiable configuration, a risk decision, a monitoring obligation, and a controlled path to change or retirement. This chapter turns policy into lifecycle gates.

Objective-led chapter6 min
06

Practitioner · Published

Risk Analysis for AI Failure and Uncertainty

AI risk analysis must move beyond a generic statement that “the model may be wrong.” The practitioner must identify how a specific error arises, how it propagates through the process, whether it can be detected, and which controls actually interrupt the chain.

Objective-led chapter6 min