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Fundamentals of Computerized Systems Validation (CSV) Part 7

Design Review

Quality Assurance - CSV - Software Validation - SDLC

Design review is an essential part of computer systems validation. At this phase, the quality of the system being built is verified at a foundational level. It does require some technical expertise and the ability to read and understand code why it is often being overlooked by regulated companies lacking those resources while suppliers don't invest their resources since it is mostly an internal process they don't need and want to share.

Source Code Review

Code should be reviewed by another person than the person who wrote it. For this procedures should be established. Some of the common issues that should be looked for are

- dead code that cannot be executed

- variables which should be declared and initialized

- security vulnerabilities e.g. SQL injection

Unit & Integration Testing

A lot of the issues in code can be detected through unit and integration testing. Again some time and resources need to be invested for this but fortunately these are tests that can be automated and reused. Today, tools exist to integrate testing and reporting with coding to streamline the development process.


An important feature of a quality driven development process is also that the requirements can be traced to the code. Any addition or modification of functionality should result in a change in code that is version controlled. For this also a myriad of tools exist nowadays to streamline and integrate with the development process.


It is not the easiest part of software quality assurance and often overlooked but has considerable impact on the quality of the final product quality. Companies that are transparent about their design review can considerably increase their trustworthiness with customers and/or regulatory authorities. Contact us for a free first consultation session.

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