CSV Software Design Validation

The core steps in the Computerized Systems Validation (CSV) process described in this series focus on three essential design aspects: identifying what the system must achieve, defining how it should be designed to meet those needs, and ensuring the design is robust and reliable.

C-Realize identifies these stages as Requirements Specification, Design Specification, and Design Review — each governed by its own disciplines within a regulated quality framework.

Requirements Specification

This stage should engage all stakeholders and subject matter experts (SMEs) to ensure a shared understanding of what is required.

Requirements should be driven by the business process, not by vendor specifications, and there is the responsibility of the regulated company.

It can also be supported by external consultants who analyze workflows and documentation. Early precision is essential – later changes tend to multiply time, effort, and cost.

Design Specification

Once user requirements are defined, the Design Specification outlines how the system will meet them. Depending on the risks, three levels of design may be documented:

• Functional Design
• Configurational Design
• Technical Design

Design Review

The Design Review is the third key stage of CSV design — verifying the quality of the system’s design.

In practice, design review is often neglected or not performed effectively. Nevertheless, system quality cannot be fully validated without it. Typical design review activities are

• Source Code Review
• Unit Testing
• Integration Testing

Modern tools now streamline both development and validation.

A robust, quality-driven development process should ensure traceablility between requirements and design. Companies that implement and document formal Design Reviews enhance both product quality and regulatory credibility.

Resources

Click on C-realize Blog to learn more about Computer System Validation risk management.

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