What are the benefits and drawbacks of using automated tools for CSV vs verification?

Tools might lag in and require to take care of: Visualization Customizations Developments, Enhancements Adaptation Expertise Business Continuity Project agility Changes in Technology Self Thinking and Acting (AI) Algorithm gaps And so on...... #Tools #Gaps

Benefits for Automation tools: There are few benefits for automation tools for CSV and Verification phase: 1. Digitalise your process 2. Easy access and quickly share your data 3. Faster approval workflow process 4. Reduce workload to provide traceability against URS to Verification 5. Easy Tools integration with process or development applications 6. Highly scalable solutions in project management 7. Regulatory compliance 8. Data Security and Privacy 9. Multiple projects implementation 10. Quickly requirements and test case creation and testing 11. Reduce the risk and errors #addcomments #benefits #autimationtools #csv

Automated testing tools can adopt for CSV and its verification challenges to reduce human error and to save time too…But at the same time organisation required trained and skilled resources. Implementation cost will be too high..

Automation Tools can be useful for Reducing the manual efforts, it will be added advantage for reducing the Release cycles. At the same time using the automation tools required lot skilled resoucre and most of the automation tools very complex.Resource training is very critical part

Benefits for automation tools are immense: It provides flexibility to author, reviewer, approver and auditors. It enhances the process of data management and data integrity.

while automated testing is often said to reduce human errors, this isn't entirely accurate. The test cases are still defined by humans, and where there is human intervention, there is always the potential for mistakes. Automated testing primarily reduces human effort during the testing phase and is more vigilant in collecting error information to track violations that might be missed during manual testing.

Requirements content changes and Test Cases content changes history was not able to update through industry leading automation tools HP ALM, Jira, Azure Devops, q-Test, TOSCA. this is one of the major drawback for using automation tool for CSV and Verification. During review and approval process of requirements and test cases “what are the changes is most important for SME review and QA approval”. Hence life sciences regulatory companies must ensure before implementing this automation tools and provide the proper URS for fit for intended use , effective CSV validation and Compliance. #addcomments #csv #automationtools #drawnacks

Automated tools have few drawbacks which are: 1) Higher initial cost 2) Configuration is required as per user requirements and wrong configuration will not help achieve the desired outcomes. 3) Every automated tools have its own limitations. limitation is required to be captured at the start of the project and a justification to be provided. 4) Automated tools require enhance testing for back up and recovery. 5) Automated tools are vulnerable to cyber attacks if not maintained properly.

- Dependency on predefined rules: Automated tools may struggle with deviations from predefined validation criteria. - Complexity handling: They may not adequately address complex validation scenarios or adapt to evolving requirements. - Initial setup and maintenance: Requires investment in time and resources for configuration, updates, and troubleshooting. - Limited customization: May lack flexibility to accommodate unique validation needs or regulatory changes. - Potential for false positives/negatives: Automated tools may inaccurately flag or miss validation issues, requiring manual verification.

Automation tools must be Qualified as per regulations . Always follow the concepts as “Qualified once and Implement many” is the best concept for qualification of automation tools. Specifically when using automation tools must qualified fit for intended use. developed, generated or stored data must be safe, secure and reliable throughout the system life cycle. Development and Automation Test Management tools: 1. TOSCA 2. Selenium’s 3. Azure Devops Test Management tools: 1. ALM 2. Jira 3. q-Test #addcomments #bestpractices #automationtools #csv

A risk based approach as per GAMP 5 edition 2 should be followed to test and validate the system / automated tool. configuration specification and testing should ensure that system is performing as intended and adheres to the local guidelines and regulatory procedures.

It’s also recommended to add clear risk based approach directions on documentation during scripted or unscripted testing to avoid extra burden of taking required/ unnecessary screenshots. What would be the workflows/ sequence of documents review and approvals for optimal turn around efficiencies. This also helps in types of defects resolution and classification. Pairing with a ad hoc review with SME or CSV/ Test Lead review before going it larger stakeholders will add clarity and also save time in understanding the level of complexity.

- Define clear validation criteria: Establish precise criteria for automated tools to follow during validation processes. - Regular updates and monitoring: Keep tools updated with the latest regulations and best practices and monitor their performance. - Validation of automated processes: Ensure the reliability and accuracy of automated validation processes through thorough testing and verification. - Documentation and audit trails: Maintain comprehensive documentation of validation activities and audit trails to ensure traceability and compliance. - Continuous improvement: Regularly review and enhance automated validation processes based on feedback, findings, and emerging industry standards.

Following shall be considered before implementation of automation tools : 1. Understand the user requirements 2. Map the user requirements into the automation tools. 3. Evaluate how the application of automation tools will simplifies the execution and how it can benefit the organisation. (Automation tool should benefit the organisation by increasing the quality, productivity and decreasing the operation cost).

- Risk assessment: Conduct comprehensive risk assessments to identify potential areas of concern and prioritize validation efforts accordingly. - Data integrity: Implement measures to safeguard data integrity throughout the validation process, including encryption and access controls. - Vendor validation: Verify the validation status of automated tool vendors and assess their compliance with regulatory requirements. - Regulatory compliance: Stay updated with relevant regulations and guidelines governing CSV in the pharmaceutical industry and ensure automated tools align with these standards. - Training and documentation: Provide training on tool usage and maintain thorough documentation of validation procedures

In contrast, manual verification allows for greater attention to detail and flexibility but is slower, less consistent, and more prone to human error. The choice between automated and manual verification will depend on the specific requirements of the task, such as the volume of data, the complexity of the datasets, and the available resources for verification processes.