Step-by-Step Computer System Validation Guide

Regulated organisations depend on digital systems that must perform accurately, securely and consistently. When a computerised system influences product quality, patient safety or data integrity, it cannot simply be installed and used without controls. It must undergo a structured validation process that demonstrates it is suitable for its intended purpose. This lifecycle approach is known as Computer System Validation, and it remains one of the most important quality responsibilities for teams operating within GxP frameworks.

Inglasia provides trusted Computer System Validation Services to organisations that operate in pharmaceuticals, biotech, laboratories, medical devices, clinical research, and other regulated sectors. Our work ensures each system is designed, tested, documented and maintained in a way that satisfies regulatory expectations and internal quality standards. To help regulated companies understand the structure behind a compliant validation effort, this guide outlines the full step-by-step process for Computer System Validation in clear and practical language.

Step 1. Defining the System’s Purpose and Scope

Every Computer System Validation activity begins with understanding what the system must achieve. The scope is defined by identifying the processes the system supports, the data it handles, the users who interact with it and the risks associated with its failure.

This stage identifies which functions are critical, which workflows require control and which regulatory rules apply. Without defining purpose and scope at the beginning, validation becomes unfocused. Inglasia’s Computer System Validation Services help teams establish clear and justified boundaries that guide the entire process.

Step 2. Creating the Validation Plan

The validation plan provides structure and guidance for all upcoming activities. It outlines the objectives, responsibilities, required documents, method of testing, acceptance criteria and change-control rules. It also identifies the validation strategy, which may vary depending on system complexity, GxP relevance and regulatory impact.

A well-written plan shows auditors that the organisation uses controlled methods, not reactive or informal processes. It ensures that every step taken is intentional and justified, which strengthens the quality position of the business.

Step 3. Writing User Requirements

User Requirements Specification documents what the system must do from the perspective of the users and the organisation. It describes the essential functionality and performance expectations. This includes access control, workflow behaviour, audit capability, reporting needs and security requirements.

These requirements act as the foundation for the validation effort. They also provide the basis for risk assessment and testing. Without accurate requirements, the validation process cannot demonstrate that the system meets actual business needs.

Step 4. Developing Functional and Design Specifications

Functional and design specifications translate user requirements into technical expectations. These documents explain how the system will achieve its intended purpose. They outline configurations, components, system logic and technical behaviours that support business goals.

These specifications ensure that every technical decision relates to validation and compliance. They also form the basis of testing during qualification. Inglasia prepares these documents as part of its Computer System Validation Services to ensure full traceability between requirements and testing.

Step 5. Conducting Risk Assessment

Risk assessment identifies potential hazards related to the system’s use. This includes risks to data integrity, product quality, regulatory compliance and operational continuity. Each risk is assessed based on impact and likelihood. The result determines which functions require more rigorous testing.

Risk assessment reduces unnecessary testing by focusing attention on the most critical features. This approach aligns with global expectations for risk-based validation. It also helps organisations use resources efficiently while maintaining strong compliance positions.

Step 6. Preparing Test Protocols

Once requirements and risks are understood, detailed test protocols are created. These protocols specify the procedures for verifying that the system behaves as intended. They include clear instructions, required evidence, acceptance criteria and expected results.

Test protocols are written for installation, operation and performance. Each protocol aligns with earlier requirements and specifications. Comprehensive test documentation reassures auditors that the validation process used a controlled and repeatable method.

Step 7. Installation Qualification

Installation Qualification verifies that the system has been installed correctly. It confirms that hardware, software and configurations match approved requirements. It also documents versions, components, network settings and environmental conditions.

This stage ensures that the system’s foundation is correct. Without Installation Qualification, later testing cannot be trusted. Inglasia’s Computer System Validation Services ensure that installation steps are documented with precision.

Step 8. Operational Qualification

Operational Qualification tests the system’s functions under controlled conditions. It verifies that the system behaves correctly according to its design and specifications. This includes functional tests, security tests, access-control tests, audit trail checks and error-handling verification.

This stage demonstrates that system behaviour is consistent and predictable. It also ensures that controls supporting data integrity are functioning. Operational Qualification is one of the key stages auditors examine during compliance inspections.

Step 9. Performance Qualification

Performance Qualification verifies that the system performs consistently under real business conditions. It confirms that typical workflows, expected data volumes and routine operational activities are supported without issues.

Performance Qualification is important because systems may behave differently under real load. This testing ensures long-term reliability. It also shows regulators that the system is suitable for the organisation’s true operating environment.

Step 10. Documenting Test Evidence

Every validation effort requires clear documentation of test results. This includes evidence such as screenshots, data outputs, confirmations, reviewer signatures and results captured in approved formats.

Proper evidence shows that testing was performed correctly and that results meet acceptance criteria. Incomplete or missing evidence can weaken the entire validation effort. Inglasia helps organisations record all required details in a clear and compliant manner.

Step 11. Managing Deviations and Corrective Actions

During testing, unexpected results can occur. These are considered deviations. Every deviation must be documented, investigated and resolved. Corrective actions may include modifying the system, adjusting configurations or updating requirements or protocols.

Proper deviation handling demonstrates strong quality governance. It shows that the organisation does not ignore issues but resolves them using a structured and documented approach. This is essential for a credible validation outcome.

Step 12. Creating the Validation Report

The validation report summarises all work performed. It confirms that each requirement has been tested, each risk has been addressed and the system meets acceptance criteria. It includes references to evidence, deviations, corrective actions and approvals.

A complete validation report provides proof that the organisation followed a structured and responsible process. It becomes a key document during inspections and internal audits. Inglasia produces validation reports as part of its Computer System Validation Services to help clients maintain a strong compliance posture.

Step 13. Implementing Change Control

Once the system is validated, it cannot be altered without review. Any change can affect validated functionality. A change-control process ensures that modifications are assessed, tested and documented. It prevents accidental or uncontrolled changes that could undermine compliance.

Change control includes reviewing updates, patches, configuration changes and process adjustments. Evaluations determine whether further testing or revalidation is required. Strong change control protects the validation status throughout the system’s life.

Step 14. Performing Periodic Reviews

Periodic reviews evaluate whether the system remains compliant, secure and reliable. Reviews examine performance, logs, access rights, incidents and audit trail activity. They also confirm that documentation and controls remain accurate and up to date.

This stage ensures the system continues to meet its intended use. It also prepares organisations for regulatory inspections by demonstrating ongoing control.

Step 15. Requalification and Revalidation

When changes occur or when performance indicators suggest that the system may require renewed verification, requalification or revalidation is necessary. This ensures the system remains aligned with business needs and regulatory expectations.

Revalidation may be triggered by software updates, system upgrades, new modules or changes in operational practice. Inglasia supports clients with risk-based requalification that prevents unnecessary work while maintaining compliance.

Step 16. System Retirement

At the end of the system’s lifecycle, a controlled retirement process ensures that data is protected and retained. Retirement includes archiving data, securing records, documenting the removal of components and ensuring no regulatory or operational obligations remain unaddressed.

A controlled retirement prevents data loss and preserves compliance. It also ensures that the organisation can demonstrate complete lifecycle governance for the system.

Why Inglasia’s Computer System Validation Services Support Compliance Throughout the Lifecycle

Inglasia provides a complete lifecycle approach to Computer System Validation. Teams gain structured documentation, clear testing strategies, accurate traceability, strong change control and long-term support. This helps regulated companies in London and across the UK maintain confidence throughout the system’s use.

By guiding clients through planning, requirements, qualification, documentation and lifecycle management, Inglasia ensures systems remain compliant, controlled and reliable. Organisations benefit from a validation framework that protects their data, their processes and their regulatory position.

FAQs

1. What are Computer System Validation Services?

They are structured, documented activities that confirm a system performs as intended, supports compliance, and maintains data integrity throughout its lifecycle.

2. Why is CSV necessary for regulated industries?

CSV ensures systems meet regulatory standards, protect data integrity, support quality decisions, and remain inspection-ready.

3. How long does the CSV process take?

The duration depends on system complexity, risk, and existing documentation. Typical projects range from several weeks for simple systems to several months for complex enterprise systems.

4. Can CSV replace software qualification?

No. Qualification confirms technical installation and operation. CSV validates the system in the context of intended use and compliance requirements.

5. How does Inglasia support CSV?

Inglasia provides planning, risk assessment, requirement specification, testing, traceability, change control, and ongoing support to maintain validated systems.

Conclusion and Call to Action

Implementing a step-by-step Computer System Validation Services program ensures systems are reliable, compliant, and inspection-ready. Each stage, from planning and risk assessment to qualification, documentation, and ongoing review, is critical to operational confidence.

With Inglasia, organisations gain expert guidance across the entire validation lifecycle, ensuring both technical reliability and regulatory compliance.

Reach out to Inglasia today to review your systems, plan validation, and maintain control throughout the lifecycle.