Setting the Scene
In the rapidly evolving landscape of computerised systems within regulated environments, the importance of rigorous Quality Assurance (QA) testing of GxP computerised systems cannot be overstated.
As we navigate through the intricacies of Computer System Validation (CSV) and the emerging focus on Computer System Assurance (CSA), it’s crucial to understand the fundamental requirements and the shift towards a quality-centric, rather than compliance-driven, approach.
The transition from traditional validation practices, characterised by Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualifications (PQs), to a more agile and risk-based assurance model reflects the industry’s commitment to enhancing patient safety and product quality.
This blog post delves into the essential aspects of QA testing for GxP computerised systems, by embracing a culture of critical thinking and focusing on the real-world application and effectiveness of computerised systems, organisations can ensure that their digital tools are not only compliant but also truly fit for their intended purpose in the highly regulated life science industry.
Breaking Down Mayet’s Commitment to Testing Excellence
Mayet’s Quality Statement
Our approach to ensuring quality in computerised systems is rooted in understanding both the traditional aspects of Computer System Validation (CSV) and the innovative principles of Computer System Assurance (CSA).
By embracing a quality-centric approach, we move beyond mere compliance to ensure that every system we validate or develop delivers real, tangible benefits to our clients and, ultimately, to the patients they serve.
How We Achieve Maximum Quality Assurance
Summarising Mayet’s Quality Strategy
- Transition from traditional CSV to agile CSA focuses on real-world effectiveness over mere compliance.
- Automated testing replaces manual QA, enhancing efficiency and reducing human error.
- Tests across major browsers ensure system functionality and robustness on all platforms.
- A zero failure release policy and GitHub integration ensure high standards and continuous integration.
- A dual-layer strategy with browser and unit testing offers comprehensive coverage
How Do We Achieve This?
- Automation and Efficiency: Automated “smoke testing” or “browser testing” replaces the traditional manual QA tester roles with an automated process. This aligns with the CSA’s emphasis on leveraging digital tools to minimise human error and enhance efficiency. The automation of testing processes ensures consistent execution of tests, reducing the likelihood of overlooking potential issues that a manual tester might miss. (See video)
- Coverage Across Major Browsers: By running tests across Edge, Safari, Firefox, and Chrome, you ensure that the application functions correctly on all major platforms, which is critical for ensuring the reliability and accessibility of the system. This comprehensive testing approach is in line with the CSA’s focus on critical thinking and risk-based adoption of computerised tools, ensuring that the system is robust across various environments.
- Comprehensive Feature Testing: Covering all features of the app in testing ensures that every aspect of the system is evaluated for its intended use, a core requirement in both CSV and CSA. This thoroughness helps in demonstrating that the system is fit for its intended use in a regulated GxP environment, addressing a key question in computer system validation.
- Zero Failure Release Policy and Continuous Integration: The requirement that changes must pass all tests before being accepted i.e. a no failure release policy. Demonstrates a commitment to maintaining the highest quality standards. This practice is supported by the use of GitHub to enforce these testing standards, which aligns with CSA principles of managing residual risk and ensuring the quality and integrity of the final product.
- Unit Testing: Hundreds of additional tests that verify the code more directly complement the browser testing by ensuring that the individual components of the application are working as expected. This level of granularity in testing, covering every single line of code, aligns with the CSA and GAMP 5 recommendations for a risk-based and critical thinking approach to validation. It ensures that potential issues are identified and resolved at the smallest unit level, contributing to the overall reliability and safety of the system.
- Dual-Layer Testing Strategy: Combining browser testing with unit testing represents a two-step testing process that provides comprehensive coverage. This dual-layer strategy ensures that both the individual components (unit tests) and the integrated system (browser tests) are thoroughly evaluated, which is a key aspect of ensuring the system’s fitness for use in a regulated environment.
This testing approach exemplifies a modern, agile, and risk-based methodology that not only meets but exceeds the regulatory requirements and expectations in the pharmaceutical sector.
By prioritising quality, efficiency, and comprehensive coverage, this strategy aligns with the shift towards Computer System Assurance and the principles outlined in the latest industry guidance, ensuring that the computerised systems used in the pharmaceutical industry are reliable, effective, and compliant with regulatory standards.
Wrapping-Up
When it comes to computerised system validation and assurance within the life sciences sector, adhering to evolving regulations and requirements is paramount. The shift from traditional CSV methods to a more dynamic CSA approach underscores the industry’s dedication to not just meet but surpass regulatory standards, ensuring that systems are not only compliant but truly serve their intended purpose in enhancing patient safety and product quality.
At Mayet, our commitment to testing excellence is more than just a compliance measure; it’s a testament to our dedication to delivering unmatched quality in computerised systems.
Our innovative testing methodologies, encompassing automated processes, comprehensive coverage across platforms, and a zero-failure release policy, exemplify our capacity to not only meet but exceed the stringent demands of the life sciences industry.
By prioritising the real-world effectiveness and reliability of our systems, Mayet stands at the forefront of supporting our clients in navigating the complex landscape of GxP compliance with confidence and assurance.
