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Enhancing Computer System Validation with Continuous Integration and Continuous Development Tools

In the dynamic landscape of software development, ensuring the reliability and effectiveness of systems is a critical endeavor. And particularly for systems used in medicines manufacturing software quality is a key aspect of Computer Systems Validation (CSV).  

In the last decade, Continuous Integration (CI) and Continuous Deployment (CD) have emerged as indispensable methodologies, offering a suite of tools and practices that streamline the software development, testing, and deployment processes. One of the most significant benefits of CI/CD for our solutions and customers, lies in the profound impact to improve how computer systems are validated in the Pharmaceutical industry. 

CI facilitates a seamless integration of code changes into a shared repository, triggering automated builds and tests. This rapid feedback loop enables early detection of defects, ensuring that issues are addressed promptly before they escalate. This capability not only reduces the overall number of defects before qualification and validation testing, but automated CI testing can be leveraged to reduce the needed number of test cases usually created for CSV purpose. 

Continuous Deployment extends the benefits of CI by automating the release of validated code changes into production environments. By integrating system validation tests into the deployment pipeline, CI/CD tools mitigate the risk of deploying flawed code, reducing the need for CSV test efforts and ultimately boosts the stability and reliability of our deployed customer applications.

Figure 1: Quality check and details on Change request in GitHub 

Automated testing, a cornerstone of CI/CD, happens at all levels such as unit tests, integration tests, and end-to-end tests and are not performed manually by humans but by software tools. By automating these tests and integrating them into the development workflow, CI/CD minimizes the risk of undetected bugs. Automated tests are not only applied in the Agile development and qualification phases but also help support our customers validation. And as the CI/CD pipeline automates both the system deployment, and configuration of service infrastructure, this ensures uniformity and reproducibility for all our internal and customer environments. 

We love our CI/CD platform as when a new product version is ready to deploy, we can deliver faster to our customer’s with great quality, consistency across development, testing, and production environments and with even more reliable Computer System Validation!

Figure 2: GoCD to monitor service health and auto-script

Figure 3: Automated workflow result in GitHub action 

Lastly, CI/CD pipelines offer comprehensive traceability and auditability throughout the software development lifecycle. Documenting every code change, test execution, and deployment activity enables our teams to track the evolution of the system and pinpoint the origin of any issues that arise.

In conclusion, adoption of CI/CD methodologies significantly enhances, and is today heavily leveraged by Computer System Validation processes. Through automated testing, consistent environments, and continuous deployment practices, we accelerate our development cycles, improve code quality, and deliver ever more reliable software solutions to meet the demands of today’s competitive Pharma manufacturing landscape.

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