Practitioner template · Version 1.0
GxP Assessment Template
Record whether and how a computerized-system use supports a regulated process, required record, calculation, control, or decision.
Nineteen controlled working aids
CSV and CSA Templates
Use the blank structures to prepare a system-specific assessment. Each template includes instructions and a completed fictional example; no template is presented as a universally required regulatory format.
Practitioner template · Version 1.0
Intended Use Template
Define what users rely on the system to do, the data and outputs involved, the operating boundary, and prohibited uses.
Practitioner template · Version 1.0
Functional Risk Assessment Template
Link each important GxP function to a failure scenario, process effect, potential consequence, controls, and required evidence.
Practitioner template · Version 1.0
Supplier Assessment Template
Evaluate whether the supplier, service controls, lifecycle practices, and available evidence are suitable for the intended use.
Practitioner template · Version 1.0
Test Strategy Template
Select a proportionate mix of scripted, unscripted, exploratory, automated, supplier, qualification, and user testing.
Practitioner template · Version 1.0
SaaS Release Assessment Template
Determine whether a supplier release affects approved GxP functions and what evidence or monitoring is required.
Practitioner template · Version 1.0
Periodic Review Template
Determine whether current operational evidence continues to support the approved intended use and validated state.
Practitioner template · Version 1.0
AI Use Assessment Template
Define and evaluate an AI-enabled GxP use, its decision authority, failure scenarios, human review, evidence, monitoring, and revalidation criteria.
Practitioner template · Version 1.0
Software Change Impact Assessment
Determine affected GxP functions, risk, regression scope, readiness, and release conditions for a software or configuration change.
Practitioner template · Version 1.0
Supplier Evidence Review
Document which supplier evidence is accepted, what it supports, its limitations, and the local validation evidence still required.
Practitioner template · Version 1.0
Interface Validation Checklist
Define and verify data meaning, mapping, error handling, retry, reconciliation, security, and monitoring across systems.
Practitioner template · Version 1.0
Data Migration Validation Plan and Checklist
Plan and verify migration scope, mapping, transformation, reconciliation, exceptions, records, signatures, relationships, access, and retrieval.
Practitioner template · Version 1.0
Spreadsheet Assessment
Assess the GxP use, formulas, data, protection, independent verification, change control, and periodic review of a spreadsheet.
Practitioner template · Version 1.0
Low-Code Application Assessment
Separate platform assurance from locally configured GxP rules, workflows, permissions, interfaces, records, and releases.
Practitioner template · Version 1.0
Automated Test Evidence Assessment
Determine whether automated testing is suitable, controlled, traceable, and capable of detecting the relevant failure.
Practitioner template · Version 1.0
User Access Review
Evaluate current user and service-account access against approved GxP roles, responsibilities, least privilege, and segregation of duties.
Practitioner template · Version 1.0
Decommissioning Checklist
Preserve required records and meaning, confirm retrieval, remove access and interfaces, terminate supplier services, and approve retirement.
Practitioner template · Version 1.0
AI Supplier Assessment
Assess the AI provider, service boundary, data handling, changes, performance information, security, continuity, and responsibilities.
Practitioner template · Version 1.0
AI Change Assessment
Determine whether an AI model, prompt, source, retrieval, parser, guardrail, workflow, or role change affects approved use or demonstrated performance.