Practitioner articles
Detailed explanations, worked reasoning, and practical guidance for software validation and assurance decisions.
28 resources in All
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.
Supplier & SaaS
A release-aware assurance model for regulated SaaS: control the decision boundary, not an imaginary frozen build.
CSV & CSA
Vendor evidence can reduce duplicate effort, but only after the customer establishes relevance, credibility, and the remaining evidence gap.
Testing
A disciplined comparison of scripted, unscripted, and hybrid evidence—plus a practical charter for high-risk workflow testing.
Testing
A team reduces its test-script count from 120 to 45 and describes the result as a successful CSA transformation. That number tells us something about the work product, but very little about confidence in the system.
Testing
A screenshot can show a displayed value, message, or state. It usually cannot establish everything about the transaction that produced it. When a test concerns an interface, a screenshot of a green status may omit the source identity, transformation, receiving record, and retry behavior.
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.
Supplier & SaaS
Commercial software can arrive with extensive supplier documentation. That documentation can reduce uncertainty and support efficient assurance, but its relevance depends on what the organization is trying to establish.
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.
Practitioner · Video and chapter
Data lineage connects a source to its transformations and use. For an AI reviewer, that may include document version, extraction, chunking, indexing, retrieval, generation, and human disposition.
Practitioner · Video and chapter
If developers repeatedly tune the prompt against the same cases and then report performance on those cases, the result may overstate performance on new work. Separate development material from evaluation material and manage access to reference answers.
Practitioner · Video and chapter
Review the supplied information about capabilities, limitations, version identification, changes, availability, security, data handling, and service terms. Then determine which questions remain about your application and use.