Validation Master Plan Checklist
A structured checklist for building or reviewing a validation master plan: scope, governance, system inventory, risk approach, deliverables and maintenance.
Practitioner resources
Checklists built from real programs — the questions worth answering before a protocol is approved, an audit begins, or a system goes live.
Planning
Equipment
Equipment IQ/OQ/PQ Planning Checklist
Plan equipment qualification properly: prerequisites, protocol content, test selection, acceptance criteria and execution readiness for IQ, OQ and PQ.
Computerized Systems
21 CFR Part 11 Assessment Checklist
Assess a system against 21 CFR Part 11: applicability, technical controls, procedural controls, signature requirements and gap documentation.
Computer Software Assurance Readiness Checklist
Evaluate whether your quality system is ready to apply a risk-based computer software assurance approach — policy, training, evidence expectations and governance.
Computerized System Risk Assessment Checklist
Structure a defensible computerized system risk assessment: intended use, functional risk, detectability, controls and residual risk documentation.
Vendor / Supplier Assessment Checklist
Assess software and equipment suppliers so their quality activities can be leveraged: QMS, development lifecycle, testing evidence, support and change notification.
Laboratory
Laboratory Equipment Qualification Checklist
Qualify laboratory instruments and equipment: DQ through PQ, calibration linkage, software and audit trail verification, and ongoing performance checks.
Data Integrity
Data Integrity Assessment Checklist
Assess data integrity risk across systems and workflows using ALCOA+ principles, data lifecycle mapping and control verification.
Process
Cleaning Validation Planning Checklist
Plan a cleaning validation program: limits basis, product grouping, sampling strategy, recovery studies, analytical methods and lifecycle monitoring.
CQV
CQV Project Startup Checklist
Start a commissioning and qualification project correctly: strategy, system classification, resourcing, vendor documentation and schedule integration.
AI
AI Validation Readiness Checklist
Evaluate readiness to deploy AI or machine learning in a GxP environment: intended use, risk, data provenance, human oversight, monitoring and change control.