Plan and document your CSV activities
Computerized system validation (CSV) is a documented, risk-based approach to establishing confidence that a computerized system is fit for its intended use. The necessary activities depend on the system's intended use, impact on product quality and patient safety, data integrity risks, applicable regulations, and organizational procedures.
Use this checklist to organize the work, identify missing evidence, document findings, assign follow-up actions, and prepare a review report. It can support an eDHR or electronic batch record implementation, but it is not a substitute for an approved validation plan or your organization's quality system.
1. Validation project details
Enter the project information that should appear in your report.
2. Validation checklist
Review each item for applicability, record the evidence, and document any gaps. Select a status for every applicable item.
3. Validation review report
Summary of project information, checklist status, evidence, and findings.
What should a computerized system validation checklist cover?
A useful checklist connects the intended use of a system to its risks, requirements, test evidence, operating controls, and approval decisions. The checklist below groups activities into practical lifecycle phases.
1. Planning and risk assessment
Define system boundaries, intended use, responsibilities, risk assessment, applicable procedures, validation strategy, and deliverables.
2. Requirements and traceability
Establish approved requirements and maintain traceability from requirements through risk controls, tests, results, deviations, and final conclusions.
3. Supplier, design, and configuration
Evaluate relevant supplier information, system configuration, interfaces, infrastructure, access controls, and the suitability of the implemented design.
4. Testing and data integrity
Execute documented tests, retain results, investigate failures, and evaluate relevant controls for records, audit trails, identity, access, backups, and recovery.
5. Release and lifecycle management
Resolve or formally disposition deviations, assess residual risk, obtain the required approvals, train users, and maintain control of changes and periodic reviews.
Frequently asked questions
What is computerized system validation?
Computerized system validation is a documented process for establishing confidence that a computerized system is suitable for its intended use. The scope and evidence should be appropriate to the system's risks, functions, and applicable requirements.
Is CSV the same as software testing?
No. Software testing can be one part of validation. Validation also involves defining intended use and requirements, assessing risks, establishing traceability, evaluating the implemented system, handling deviations, maintaining evidence, and controlling the system throughout its lifecycle.
Does every system need the same validation activities?
No. Validation should be tailored to intended use, risk, system complexity, supplier information, configuration, and applicable regulatory and quality requirements. Document the rationale for the chosen scope and any exclusions.
What is requirements traceability?
Traceability connects requirements to relevant risks, controls, test cases, test results, deviations, and conclusions. It helps reviewers understand whether the intended functions were evaluated and whether identified risks were adequately addressed.
Can I use this checklist as my formal validation plan?
This tool is a planning aid. A formal validation plan may require approved scope, responsibilities, deliverables, acceptance criteria, risk-based rationale, procedures, and approval steps specific to your organization. Adapt and control any documents used in your quality system.
Does completing this checklist prove compliance with 21 CFR Part 11?
No. Checklist completion is not proof of compliance. Applicability and required controls depend on the records and signatures involved, intended use, applicable regulations, system implementation, and the organization's documented assessment.
Official references
- 21 CFR Part 11 — Electronic Records; Electronic Signatures
- FDA guidance — Part 11: Scope and Application
- FDA medical device information
- FDA guidance documents search
This page provides general educational information. It is not legal, regulatory, quality, or validation advice. Confirm applicable requirements with qualified personnel and current official guidance.