Computer System Validation (CSV) is a structured, risk-based approach used to establish documented confidence that a computerized system is fit for its intended use and operates in a controlled state within its regulated environment.
Educational note: Specific requirements and applicability should always be assessed against the system, process, organization and applicable regulations.
CSV is the documented process of demonstrating that a computerized system consistently performs its intended functions and that the controls surrounding the system are appropriate for its GxP use.
It is not simply a collection of test scripts. Effective validation considers intended use, risks, requirements, configuration, testing, data, interfaces, suppliers, users and lifecycle controls.
Start with intended use and risk. The assurance effort should be proportionate to the potential impact on patient safety, product quality, data integrity and regulated processes.
Define what the system does, who uses it, which process it supports and which GxP records or decisions depend on it.
Identify critical functions, data, interfaces, calculations, controls and failure modes that could affect GxP outcomes.
Use risk to determine the appropriate requirements, testing, review and evidence.
Continue control through changes, incidents, periodic review, access, backup, security and retirement.
| Area | Typical evidence | Purpose |
|---|---|---|
| Strategy | Validation / assurance strategy | Defines scope, approach and responsibilities. |
| Requirements | User / functional / system requirements | Defines what the system needs to do. |
| Risk | GxP / functional risk assessment | Identifies critical functions and proportionate assurance. |
| Design | Design / configuration records | Describes solution structure and configuration. |
| Testing | Protocols, scripts and evidence | Provides objective verification evidence. |
| Traceability | Requirements-to-test traceability | Demonstrates applicable coverage. |
| Summary | Validation summary / report | Summarizes activities, results and conclusion. |
| Lifecycle | Change, review and retirement records | Maintains the controlled state over time. |
Demonstrates intended functions work correctly under expected conditions.
Where appropriate, challenges controls and error handling.
Considers critical data flows, transfers, calculations and interfaces where applicable.
Checks that results are complete, attributable, contemporaneous and clear enough to support conclusions.
Computer Software Assurance (CSA) is commonly discussed as a risk-based approach to software assurance. The terminology and methodology should follow the organization's quality system and applicable regulatory expectations.
A process can become overly focused on producing documents and large numbers of tests without distinguishing critical from low-risk functionality.
Start with intended use and risk, then apply proportionate assurance activities and evidence to the functions and controls that matter most.
Assess impact and determine appropriate testing or requalification before implementation.
Confirm the system remains fit for intended use and relevant controls remain appropriate.
Assess and manage issues that may affect GxP processes or data.
Maintain appropriate authorization, segregation and protection of GxP data.
Maintain recovery arrangements appropriate to business and GxP requirements.
Protect required records, retention obligations, data integrity and traceability.
Electronic records and electronic signatures requirements relevant to regulated records and systems within scope.
Principles for computerized systems used in GMP-regulated environments.
Industry guidance supporting a risk-based approach to computerized systems.
Considerations around reliable, complete, consistent and controlled GxP data throughout its lifecycle.
Whether the system is GxP-critical, Non-GxP, SOX-related or part of a broader controlled process, ILAP Advisory can help you understand the scope, risk and appropriate assurance approach.
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