How do you select and evaluate software validation tools and methods?

Software validation tools are indispensable in the GxP industry. -They centralize control, reducing risks. -They enhance productivity with faster decision-making. -They improve product quality, reducing defects and recalls. -They promote continuous improvement by monitoring system changes. These tools are essential for efficient and compliant operations.

You need software validation tools to control and prevent "validation by the pound". Starting with a list of requirements, and CSA mentality, only some medium and most high risk requirements need to be tested locally, and only if they apply to YOUR use of the system. All other should have been tested by the vendor, and any reasonable audit of the vendor will suffice.

Software Validations tools are necessary to demonstrate proper control over system testing of functional requirements, and the mapping to their user requirements and other predicate rule records. In large, complex systems there is no other way to maintain traceability and approval flows from CR -> requirements -> test case(s) -> defects -> release # and vice versa and to quickly generate information for regulatory inspections and Sponsor audits. Most validation tools require a project template, i.e., method to control the mapping, flow and security of the above. Without a procedural definition to use a validation tool, adequate control as required by the CFRs is lost, and test script reusability suffers.

Most FDA regulated organizations use a combination of tools to perform software validation. Some will be electronic such as HP-ALM for end-to-end traceability, but some tools in the validation process can also be procedural such as how to perform a requirements risk assessment, team-based code review, or system architecture review. The output of some tools, such as HP-ALM is likely to have high visibility in audits/inspections, while there are lesser electronic tools, such as GitHub/Lab that perform software version control or tools like ServiceNow to track a Change Control. All of the tools contain predicate rule info for the computer system and are important. However, focusing resources by inspection/audit risks is the key.

Selecting software validation tools and methods involves considering factors like software type, complexity, intended use, risk level, validation strategy, standards, and budget. At White Internet Consulting, we faced this when validating a complex health tech solution. We chose tools that matched our software's requirements and were compatible with our development lifecycle. Ensuring compliance with regulations, we opted for reliable, user-friendly, and scalable tools. Balancing cost-effectiveness and efficiency was key. This approach not only met validation objectives but also streamlined our processes, ensuring a robust and compliant solution.

Here are a few key systematic approaches: 1. Define Requirements: • Clearly define your software validation requirements based on regulatory standards • Identify the types of systems and applications that need validation. 2. Regulatory Compliance: • Ensure that the selected tools and methods comply with relevant regulations 3. Risk Assessment: • Perform a risk assessment to identify critical aspects of the software that require validation. • Prioritize validation efforts based on risk. 4. Vendor Reputation

When choosing a tool, key factors to consider are -compatibility with existing systems, -functionality to meet project needs, -scalability for future growth, -user-friendliness, -reliable support, -customization options, -user feedback, -compliance with regulations, -vendor reputation, -long-term viability. Each factor's importance varies based on specific requirements. A detailed requirement list helps in making an informed decision.

In line with the selection of software validation tools and methods, it's crucial to consider the regulatory environment, especially for industries like pharmaceuticals and biotechnology. Compliance with guidelines such as 21 CFR §11, FDA/EMA regulations, ICH-GCP, and Eudralex is non-negotiable. Furthermore, the selection should also factor in the system development life cycle (SDLC) model in use, be it Agile, DevOps, Waterfall, V-model, or SAFe, as the validation tool should seamlessly integrate with these processes. Lastly, the tool's ability to support risk assessments and RBQM is essential for maintaining quality and regulatory compliance. In the regulated world, a Vendor Supplier Audit is performed against requirements.

It should be affordable, easy to use, and capable of being automated or executed manually. Otherwise, we are better off with just a well written set of policies and SOPs.

Validation software tools should be easy to use and understand by any mid level validation employee. It should also support automation.

In the context of Computer System Validation (CSV), evaluating software validation tools and methods is a critical step. It's important to remember that the tools and methods selected should align with regulatory guidelines such as 21 CFR §11, FDA/EMA regulations, ICH-GCP, and Eudralex. Vendor Supplier audits can provide valuable insights into the effectiveness of these tools and methods. They can highlight potential risks and areas for improvement, aiding in the decision-making process for updates or changes.

Here are some ways; - Early Testing: Check for problems in the beginning stages of making software. -Containerization: Keep everything consistent no matter where it runs. -Code Review Tools: Use tools to make sure your code is good and safe. -Traceability Matrices: Connect what you need to do with what you're testing. -Continuous Deployment: Release new stuff quickly and reliably. -Retrospectives: Learn from the past to get better each time.

The first requirement of a validation tool is to capture system requirements. They should be ranked based on "risk", and testable via automation. The end goal is to prevent "validation by the pound", to be efficient and not add significantly to the implementation timeline. Validation documentation should be automatically generated. Using any validation tool should mirror the minimum standards based on the FDA's guidances. It should be logical and easy to teach to new users.

In my experience, a significant challenge in improving software validation tools and methods is ensuring that these enhancements align with regulatory guidelines such as 21 CFR §11, FDA/EMA regulations, ICH-GCP, and Eudralex. The solution lies in a rigorous review and update of validation requirements and specifications, coupled with regular training for users and stakeholders. This ensures that any changes or improvements made are compliant with regulations, thereby reducing the risk of non-compliance during sponsor audits and regulatory inspections. Reducing software validation time by focusing on the high-risk functionality is a good best practice to follow. But make sure the requirements risk assessment is documented.