What are the best tools for testing and verifying your computer system validation outcomes?

Adding to this point, CSV needs to evolve to fit the agile or agile like development and testing environments now gaining traction quickly in health tech. Something like the Atlassian suite goes a long way to enshrine dev ops type sdlcs and with the correct amount of discipline , stay within the boundaries of regulations.

1) Start by defining the problem statement. 2) Determine scope, risk, and impact to organization. 3) Develop a project plan and execution strategy. 4) Contact me for additional information.

Designing and executing effective testing strategies for Computer Systems Validation (CSV) requires careful consideration of various factors, including system complexity, validation lifecycle stages, and industry standards. Here are some key testing strategies commonly employed in CSV: Unit Testing, Integration Testing, System Testing, and User Acceptance Testing (UAT). To implement testing strategies for CSV, and align them with validation lifecycle stages, regulations, and industry best practices. Prioritize testing based on system components' complexity and criticality to optimize resources and ensure thorough validation coverage. Successful validation outcomes from stakeholders, developers, testers, and validation experts.

Effective Test strategies can be defined based on risk based approach. Risk assessment should conducted for every requirement identify the risk associated with it. And this can leads to defined risk based validation plan and Test Plan. Best way to defined test strategies: 1. Business process risk assessment 2. Deferentiate business , functional, regulatory, global, security requirements. 3. Applying critical thinking on every requirement and do the business process requirement. 4. Prepared risk based validation plan& Test Plan and defined test strategies #addcomments #csv #testplan

Many tools are there like valgenesis, agile, jira, atlassian, node js will help the effective validation of computerised systems applications/software/systems

Unfortunately industry wide we have conflated software quality testing and computerized system validation. Good software quality engineering practices and testing when done in conjunction with computerized system validation - there need not be separate activities. We have the opportunity as an industry to make this a seamless process.

i would like to emphasize that implementing csv as early as possible in unit level might possibly "delay" delivery timing but also save much debug time of bugs that are found in system level which are much hard to identify and solve.

Identify the scope of functional requirement and start apply critical thinking and propose the strategies to the ways of validate the functionality gives the prepare risk based test strategies and validation on complex systems and ERP based IT systems. #addcomments #csv #teststrategies #testing #lifescience

Several Computer System Validation tools are available, like Polarion by Siemens, Kneat, Valgenesis, and Veeva Validation Solution. However, before choosing a tool (manual or automatic), assess if your paper-based process is insufficient. Efficient manual testing, using Unscripted testing and a risk-based approach, can be effective. It's wise to achieve a level of testing maturity before investing heavily in tools, based on my 20 years of managing testing teams and tools.

There should be no distinction between software quality testing tools, leaders in the field OpenText, Atlassian, IBM as well as open source test automation tools need to be the main landscape of an organization. Some software is more configurable than others what and how mature your testing organization is will determine what is best to scale with your team. All of these tools - and they are tools- do not need to be validated they only need to be qualified. This is FDA recommendations in new CSA guidance. Validation lifecycle management tools like Kneat, Valgenesis, etc can assist in managing ‘document’ centric approaches and rapidly increasing API capabilities to stand software quality testing tools.

Testing tools are play a vital role in test management. Many of testing tools are available in market for testing management from initial requirements gathered and Test plans preparation and execution. Ex: HP ALM, q-Test, Devops, TOSCA, Selenium, Valgensis, e-Val etc Best Key features for testing tools: 1. Tools can able trace the requirement, Test Plan changes . 2. Audit trial should be generate for every event or action in tool. 3. Tools cannot support any deletion of requirements and Test Plan , Test Runs and Defect IDs. 4. All testing tools should be Qualified as per regulations #addcomments #csv #testingtools

Yes, we can use these tools during CSV; however, it's important to note that in GxP industries, all tools used must be validated, and their use should adhere to the relevant regulatory standards and guidelines. Validation documentation, risk assessments, and change control processes are essential for ensuring that these tools are used in a compliant and controlled manner. Proper use of these tools streamlines processes and maintains compliance and data integrity.

Indeed, selecting the right testing tools is crucial for ensuring the quality and efficiency of CSV (Comma-Separated Values) files. Here's an overview of common testing tools categorized according to their functions. Several Computer System Validation tools are available, like HP ALM now Micro Focus ALM, IBM rational quality manager, and Micro soft test manager. Test automation tools like Selenium, Ranorex, and Test Complete. Test data generation tools like SQL data generator, Mockaroo, and Faker. Test performance tools like J Meter, Load Runner, and Blaze Meter. These tools can be combined and customized according to specific testing requirements and project constraints to ensure effective testing of CSV files and associated systems.

CSV verification involves diverse techniques: - Risk-Based Testing: Prioritize testing based on impact. - Regression Testing: Ensure updates don't harm existing functionalities. - Change Control: Rigorous procedures for system changes. - Data Integrity Checks: Verify accurate data input, processing, and retrieval. - Performance Testing: Assess system performance under various conditions. - Security Testing: Confirm protection against unauthorized access. - User Acceptance Testing (UAT): Involve end-users for feedback. - Documentation Review: Keep all documentation updated and reflective of the system's current state.

As per FDA new proposed CSA guideline Verification should be done based on risk of the requirement and build. Each sprint should be thoroughly tested and documented. Extensive testing can be defined based risk level , High risk requirements should be required E2E testing, regression testing, scripted testing with OQ Test plan. Medium risk requirements can be tested E2E testing , scripted testing with OQ test plans. If low risk requirements should be tested by ad-hoc method, Unscripted testing #addcomments #csv #verification

Maintaining the flexibility and adaptability of the documentation and verification plan is crucial in any project, particularly: Requirement Changes, Risk Management, Regulatory Compliance, Technology Advancements, Feedback, and Lessons Learned and Project Scope and Timeline. By recognizing that the documentation and verification plan are dynamic documents that evolve throughout the project, teams can better adapt to changes, mitigate risks, and ensure the ongoing effectiveness of the testing and validation processes. Regular reviews and updates to these documents enable teams to maintain alignment with project goals and stakeholder expectations, ultimately contributing to the successful delivery of the project.

one should also bear in mind that not only the documentation and verification plan are important, but also that this is a DYNAMIC document that keeps changing and evolving during the project.

Verification testing rationale should be documented in the Validation plan and tests will be in accordance with the URS. Traceability matrix will ensure that each User requirements are met. Impact assessment will ensure that right comments are being tested. A pre approved test protocol is required for IQOQ and UAT. Each documents required a report to summarise the results and any deviations taking place part of that activity. A VSR is required to conclude the project.

Selecting the best testing tool is crucial for optimal CSV validation. However, it's important to recognize that CSV standards are globally applicable, even in regions without access to sophisticated systems and resources like those of many large organizations. Budget, company size, and revenue are significant factors. Regardless of the tools used or the practices followed, maintaining integrity in CSV validation—whether automated or manual, digital or paper-based—is highly commendable.