GxP Assessment Template
Record whether and how a computerized-system use supports a regulated process, required record, calculation, control, or decision.
Resources / Working aids
Worksheets & Templates
Find a starting point for assessment, planning, testing, release, operations or retirement.
30 of 30 working aids
Intended Use Template
Define what users rely on the system to do, the data and outputs involved, the operating boundary, and prohibited uses.
Functional Risk Assessment Template
Link each important GxP function to a failure scenario, process effect, potential consequence, controls, and required evidence.
Supplier Assessment Template
Evaluate whether the supplier, service controls, lifecycle practices, and available evidence are suitable for the intended use.
Test Strategy Template
Select a proportionate mix of scripted, unscripted, exploratory, automated, supplier, qualification, and user testing.
SaaS Release Assessment Template
Determine whether a supplier release affects approved GxP functions and what evidence or monitoring is required.
Periodic Review Template
Determine whether current operational evidence continues to support the approved intended use and validated state.
AI Use Assessment Template
Define and evaluate an AI-enabled GxP use, its decision authority, failure scenarios, human review, evidence, monitoring, and revalidation criteria.
Software Change Impact Assessment
Determine affected GxP functions, risk, regression scope, readiness, and release conditions for a software or configuration change.
Supplier Evidence Review
Document which supplier evidence is accepted, what it supports, its limitations, and the local validation evidence still required.
Interface Validation Checklist
Define and verify data meaning, mapping, error handling, retry, reconciliation, security, and monitoring across systems.
Data Migration Validation Plan and Checklist
Plan and verify migration scope, mapping, transformation, reconciliation, exceptions, records, signatures, relationships, access, and retrieval.
Spreadsheet Assessment
Assess the GxP use, formulas, data, protection, independent verification, change control, and periodic review of a spreadsheet.
Low-Code Application Assessment
Separate platform assurance from locally configured GxP rules, workflows, permissions, interfaces, records, and releases.
Automated Test Evidence Assessment
Determine whether automated testing is suitable, controlled, traceable, and capable of detecting the relevant failure.
User Access Review
Evaluate current user and service-account access against approved GxP roles, responsibilities, least privilege, and segregation of duties.
Decommissioning Checklist
Preserve required records and meaning, confirm retrieval, remove access and interfaces, terminate supplier services, and approve retirement.
AI Supplier Assessment
Assess the AI provider, service boundary, data handling, changes, performance information, security, continuity, and responsibilities.
AI Change Assessment
Determine whether an AI model, prompt, source, retrieval, parser, guardrail, workflow, or role change affects approved use or demonstrated performance.
Exploratory Test Charter
Define the purpose, scope, risks, and evidence to capture during exploratory testing.
AI Evaluation Scorecard
Record expected results, AI findings, missed issues, and performance measures for a defined task.
Validation Summary Worksheet
Summarise completed testing, unresolved deviations, residual risks, and the conclusion supporting release.
AI intended-use statement
Define the proposed use precisely enough to select risks, controls and evidence.
AI GxP assessment
Record actual use, influence and the requirements that need a local applicability decision.
AI functional risk assessment
Connect a specific failure to its consequences, controls, tests and residual-risk decision.
AI supplier assessment
Decide which supplier evidence supports your use and which responsibilities or gaps remain local.
AI performance evaluation
Record issue-level results and retain a traceable basis for metrics and the decision.
AI human-review evaluation
Test whether the complete review workflow delivers the risk reduction being claimed.
AI validation summary
Reconcile the evidence, failures and operating restrictions into an assessable release decision.
AI monitoring and change assessment
Connect signals and changes to impact, containment, evidence and continued-use decisions.