Validation project details
Provide the system and project context. Then adapt the starter tasks to your system's intended use, risk assessment, quality procedures, and applicable requirements.
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1. Validation tasks and deliverables
Review the suggested tasks, assign responsible roles, and record the evidence references used by your organization. Not every task applies to every system; document justified exclusions.
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Validation reminder: choose activities and evidence based on intended use, risk, supplier information, configuration, and applicable requirements. This generic template does not determine which regulatory controls apply to your system.
2. Computerized System Validation Plan
Interpretation: progress and gap indicators are calculated from the entries provided. They are planning aids only and do not constitute validation approval, a compliance determination, or authorization to use a system in production.
Validation activity plan
| Task ID | Phase | Activity | Deliverable | Risk | Owner | Evidence reference | Status | Plan flags | Notes |
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Outstanding items and gaps
Recommended next actions
What is computerized system validation?
Computerized system validation (CSV) is a documented, risk-informed process for establishing confidence that a computerized system is suitable for its intended use. In regulated manufacturing, the scope of activities should reflect the system's functions, risks, configuration, supplier evidence, and the organization's quality system.
What should a validation plan cover?
- Intended use and scope: define the system boundaries, users, interfaces, and processes.
- Risk assessment: identify risks to product quality, patient safety where relevant, record integrity, and process control.
- Requirements and design: define what the system must do and how relevant functions are configured or controlled.
- Verification and testing: document the test strategy, prerequisites, acceptance criteria, execution evidence, and handling of failures.
- Data integrity and electronic records: evaluate applicable access controls, audit trails, retention, recovery, signatures, and record-management requirements.
- Traceability: link requirements and risk controls to verification activities and documented results.
- Closeout and lifecycle controls: resolve outstanding issues, document conclusions, obtain approvals, and establish change control and periodic review as appropriate.
Risk-based validation
A risk-based approach focuses effort on functions and controls that matter most to the system's intended use and regulated processes. The risk method, acceptance criteria, and required evidence should be defined and approved by the responsible organization. Risk ratings in this tool are user-entered planning labels, not an automated risk assessment.
Using supplier documentation
Supplier specifications, testing, release notes, security documentation, and other available evidence may contribute to a validation strategy when assessed for relevance, reliability, and suitability. Determine and document any additional verification needed for your configured system, interfaces, workflows, and actual use.
How to use this generator
- Define the system, intended use, project stage, and validation responsibilities.
- Review the starter activities and tailor them to your approved procedures.
- Assign an owner and expected deliverable to each applicable task.
- Record evidence references as work is performed and update task status.
- Generate the plan, review the gaps, and export the working document.
- Review, approve, and maintain the final validation plan through document control.