Computerised systems play an essential role in regulated environments. Pharmaceutical manufacturers, biotech organisations, laboratories, medical device companies and clinical research teams rely on digital platforms to produce, store or process data that influences patient safety and product quality. Because of this, regulators expect organisations to demonstrate that these systems function correctly and remain under control throughout their lifecycle. This is achieved through Computer System Validation, which depends on accurate and complete documentation at every stage of the process.

Inglasia supports organisations across London and the wider UK with trusted Computer System Validation Services designed to meet GxP expectations. One of the most frequent challenges clients face is understanding which documents are required and how these documents work together to support inspection readiness. This article explains the most common CSV documentation requirements and clarifies their purpose within a compliant validation lifecycle.

The Importance of Documentation in CSV

Documentation is the foundation of every validation effort. Regulators do not rely on verbal assurance or informal explanations. They expect written evidence that shows how a system was selected, tested, assessed, approved and monitored. This evidence must be clear, consistent and traceable.

Documentation is not a formality. It protects the organisation by demonstrating that processes were controlled, risks were understood and testing was completed according to approved plans. Without strong documentation, even well executed validation activities can appear incomplete. This is why Inglasia’s Computer System Validation Services place significant emphasis on creating, reviewing and maintaining documentation throughout the lifecycle.

Validation Master Plan

A Validation Master Plan is the starting point for any CSV program. It outlines the validation strategy and defines how the organisation intends to approach system validation. It includes scope, responsibilities, deliverables, timelines, required documentation and methods for change control.

This document gives auditors confidence that the organisation follows a structured and intentional approach. It also guides internal teams by setting expectations and preventing inconsistencies between projects.

User Requirements Specification

A User Requirements Specification describes what the system needs to achieve. It documents the business goals, key functions, necessary controls, users and data interactions. The URS is important because it defines the basis for testing and risk assessment.

Every requirement must be clear, measurable and testable. If a requirement is vague or incomplete, it becomes difficult to demonstrate that the system is truly fit for purpose. Inglasia ensures that requirements reflect real business needs before validation begins, which strengthens both test coverage and inspection readiness.

Functional and Design Specifications

Functional and design specifications translate user requirements into technical terms. These documents explain how the system will operate, how components will interact and which configurations or settings support intended use.

Functional specifications describe expected system behaviour. Design specifications describe the technical structure that enables this behaviour. Together they provide traceability between requirements and testing. They also help regulators understand the logic behind system choices.

Specifications must be maintained throughout the lifecycle. If updates occur, the specifications need to be reviewed and updated to reflect any changes in system configuration or purpose.

Risk Assessment

Risk assessment is central to modern CSV. It identifies potential hazards related to system failure, data integrity issues or process interruptions. Risks are assessed based on their potential impact and the likelihood of occurrence.

This documentation directs testing priorities. High risk functions require more detailed testing. Lower risk functions may require only basic verification. Risk assessment also supports decisions during change control and revalidation. Inglasia’s Computer System Validation Services use risk-based approaches to ensure testing is justified, controlled and aligned with regulatory expectations.

Test Plans and Test Protocols

Test plans describe the overall testing strategy. Test protocols provide the detailed instructions for each test. These documents specify test steps, expected results, acceptance criteria and the required evidence.

There are typically three categories of test protocols associated with validation. Installation testing verifies that the system has been installed correctly. Operational testing confirms that the system behaves as designed. Performance testing verifies that the system can support real business workflows.

Test plans and protocols must be approved before testing begins. This demonstrates that testing has been planned and reviewed and is not being created after the fact.

Test Evidence and Test Results

Test evidence is essential for proving that validation activities were performed. Evidence may include screenshots, data extracts, signed checklists, system logs or documented results. Each piece of evidence must be linked directly to its corresponding test step.

Test results must be reviewed and approved by authorised individuals. Results must also be clear and accurate. Any steps that did not meet the expected outcome require documented investigation.

Without clear test evidence, validation cannot be considered complete. Regulators expect to see a full record that shows exactly how the system was evaluated.

Deviation and Issue Logs

During testing, deviations can occur. A deviation is any unexpected result, incomplete step or behaviour that does not match the expected outcome. These events must be documented fully. Each deviation requires investigation, assessment, resolution and approval.

Deviation logs show regulators that the organisation has a responsible approach to issues. They demonstrate that testing was real and not prepared only for inspection. Inglasia guides clients through issue logging, root cause analysis and corrective action documentation to ensure full compliance.

Traceability Matrix

A traceability matrix connects each requirement to the tests that verify it. This document shows that all requirements have been addressed and that no critical functionality has been overlooked. It also supports impact assessment when changes occur because it highlights which areas of the system may be affected.

Traceability is one of the most important aspects of CSV documentation. Without it, auditors cannot quickly evaluate whether test coverage aligns with requirements. Inglasia includes traceability matrices as standard in its Computer System Validation Services to provide clarity and transparency.

Validation Summary Report

The Validation Summary Report consolidates all validation activities. It confirms that validation was conducted according to the plan. It summarises test results, deviations, resolutions and final conclusions. It states whether the system is considered validated and ready for use.

A clear and well structured summary report provides strong audit support. It shows that the organisation has completed every required step and can justify system readiness.

Operational Procedures and User Guides

CSV documentation does not end when testing is complete. Operational procedures and user guides must be in place to support safe and consistent system use. These documents describe how the system should be used, how data should be handled, how user access should be managed and how routine operations should be performed.

Procedures also cover incident reporting, backup practices, data retention, archiving, periodic reviews and maintenance scheduling. These documents ensure that system use remains controlled over time.

Change Control Documentation

Once a system is validated, any change must be managed through change control. Change control documentation assesses the impact of updates, patches, configuration changes or process modifications.

These records document the reason for the change, the associated risk assessment, required testing and approvals. Change control demonstrates that the organisation understands how modifications can influence validated functions and takes appropriate steps to maintain compliance.

Periodic Review Records

Periodic reviews evaluate the ongoing performance and compliance of the system. These reviews examine access rights, audit trails, system logs, environmental conditions, training records and operational incidents. They confirm that the system remains suitable for its intended use.

Review records provide evidence that the organisation is not treating validation as a one time activity. They demonstrate ongoing control, which is essential for strong compliance positions.

Retirement Documentation

When a system reaches the end of its lifecycle, retirement must be documented. This includes steps to archive data, revoke access, secure records and remove components safely. Retirement documentation protects organisations from data loss and ensures that regulatory obligations continue to be met.

It also provides traceability should auditors question historical data or system access.

Why Organisations Trust Inglasia for CSV Documentation

Inglasia supports clients throughout the full lifecycle with comprehensive Computer System Validation Services. This includes creating, reviewing and managing documentation from initial planning to system retirement. With deep experience in regulated industries, Inglasia helps teams achieve documentation that is precise, complete and audit ready.

Documentation is more than a requirement. It is evidence that the organisation has taken every necessary step to protect patient safety, product quality and data integrity. With Inglasia’s guidance, regulated organisations can maintain confidence in their systems and reduce exposure to compliance risk.

 FAQs

1. Which documents are required for CSV?

Most CSV projects need a Validation Plan, User Requirements, Functional and Design Specifications, Risk Assessments, IQ/OQ/PQ protocols, Test Reports, a Traceability Matrix and a Validation Summary Report.

2. How does Inglasia support CSV documentation?

Inglasia prepares and organises all required documents, builds templates, guides requirement development, writes protocols and reports, and ensures every document meets GxP expectations.

3. Why is CSV documentation important?

It provides evidence that systems work correctly and stay under control. Regulators rely on this documentation to confirm traceability, testing coverage and compliance.

4. Can Inglasia fix incomplete or outdated CSV files?

Yes. Inglasia reviews your current documents, identifies gaps and updates or replaces items so your validation package meets inspection standards.

5. What does a Validation Plan do?

It outlines the scope, responsibilities, testing approach and lifecycle activities for the system. Inglasia creates Validation Plans aligned with regulatory requirements.

6. Why is a Traceability Matrix needed?

It links requirements to tests and evidence. Inglasia builds matrices that clearly show complete coverage for audits.

7. Does Inglasia align documentation with global regulations?

Yes. All documents follow GAMP 5, EU GMP Annex 11 and 21 CFR Part 11 principles.

8. Does Inglasia offer support after initial validation?

Yes. Inglasia maintains documents through updates, periodic reviews and change control activities.

9. Can Inglasia help with inspection readiness?

Yes. Inglasia reviews your documentation, identifies gaps and prepares evidence for audits.

10. What sets Inglasia’s CSV documentation services apart?

Inglasia provides clear, structured documentation and practical compliance support that helps teams pass inspections confidently.

Final Call to Action

If your organisation relies on digital systems to manage regulated processes, the strength of your documentation determines the strength of your compliance position. Clear records, structured testing and controlled lifecycle management give you the confidence that every system in use can support consistent, reliable and traceable operations. Inglasia’s Computer System Validation Services provide the structure, expertise and support needed to achieve this level of assurance.

If you want to review your documentation, improve your validation approach or prepare for upcoming inspections, reach out to Inglasia today. Our team is ready to help you build documentation that supports compliance, protects your workflows and meets the expectations of regulators and auditors.