Eight methods for CSV projects
Use these methods inside the validation plan, functional risk assessment, supplier assessment, test strategy, change control, VSR, and periodic review. They supplement—not replace—your approved validation SOP.
These methods organize familiar activities: defining scope, assessing failure, reviewing evidence, testing, and maintaining confidence. They are educational methods, not regulatory standards or independently established novel inventions. Use them alongside your approved procedures. Choose the method that fits the question. Function-Level Risk Assessment separates materially different GxP uses. Existing Evidence Assessment tests whether prior evidence supports the current use. Risk-Based Test Selection helps choose additional activities. SaaS Release Impact Assessment evaluates updates. AI Use Controls define permitted behavior. Validation Rationale explains the decision. Maintaining the Validated State keeps the basis current. AI-Assisted Document Review evaluates a specific assisted-review workflow.
Practitioner method · Not a regulatory standard
A GxP function is a bounded use that you can describe, assess, and support with evidence. It is an assessment aid, not necessarily a screen, module, or microservice.
Method, worked example, and worksheet →Practitioner method · Not a regulatory standard
Evidence is reusable when its relevance and limitations are understood. This method asks progressively stronger questions; it does not rank documents by prestige.
Method, worked example, and worksheet →Practitioner method · Not a regulatory standard
Choose testing by asking what you still need to learn. This method considers failure consequence, complexity and variability, existing evidence, and the need for precise reproducibility.
Method, worked example, and worksheet →Practitioner method · Not a regulatory standard
A supplier release note is the starting point for local assessment. It may not describe every dependency relevant to your configuration.
Method, worked example, and worksheet →Practitioner method · Not a regulatory standard
AI use controls define the conditions within which an AI-assisted workflow is permitted to operate. They cover input, sources, output, authority, human review, technical permissions, and stop conditions.
Method, worked example, and worksheet →Practitioner method · Not a regulatory standard
A useful explanation lets another qualified person follow the decision without relying on confidence or presentation style. Start with the actual process and show the connection to evidence.
Method, worked example, and worksheet →Practitioner method · Not a regulatory standard
Maintaining the validated state requires a current explanation of why the approved system use remains supported. This method connects claims, assumptions, evidence, owners, and events that could invalidate the conclusion.
Method, worked example, and worksheet →Practitioner method · Not a regulatory standard
This method evaluates an assistant that suggests document-review findings. It does not treat generated findings as approved quality conclusions.
Method, worked example, and worksheet →