Developing a new product or service? Want to make sure it’s good? Validation can help. Here’s a 5-step process to check and document if your product meets requirements and satisfies customers. Follow these steps to test and validate your product before it goes to market. This saves time and resources. Ready to learn more? Let’s get started.

Step 1: Planning Your Validation

Understanding What Validation Means

Validation in the context of a system or process means confirming that the requirements for a specific use have been met. The purpose is to ensure consistent production of results meeting predetermined specifications. Understanding validation impacts the planning and execution of validation activities by providing a clear framework. It helps organizations set concrete goals and requirements, enabling practical validation activities. This understanding leads to reduced errors in later project stages.

A clear understanding of validation is vital for determining which activities to include when creating a validation plan. It ensures the plan focuses on objective evidence and aims to produce practical and reliable results, thereby increasing the system or process reliability.

Writing Your Validation Plan

A validation plan has two main parts:

1. Formal proof of properties from upper-level requirements.
2. Functional tests based on the next-level specification.

The formal proof aims to catch errors in the early stages of development. This ensures that the validation plan meets system needs.

Experts introduce assertions and verify imported code after achieving formal proof. This documents test instructions and results.

These measures are important for a well-structured validation plan. They demonstrate consistent product quality and meet predetermined specifications, as defined by the FDA for process validation.

Step 2: What You Need for Validation

Listing Your System’s Needs

The system’s validation process requires specific hardware and software that match its intended use or application. For example, the system may need a certified code generator, strong typing, and formal verification to minimize test efforts and ensure compliance with safety requirements.

Environmental conditions, like production facilities, also need consideration to ensure that the system’s validation process accounts for its operating environment and other relevant conditions.

Furthermore, the system’s validation process must meet specific regulatory or industry standards. For instance, the CENELEC EN 50128 standard may recommend using formal methods in the requirement specification for software SSIL4. The FDA explicitly defines process validation as establishing that a process consistently produces a result or product meeting its predetermined specifications.

Setting Clear Requirements

Setting clear requirements for validation is very important in the application validation process.

The key elements to consider when setting clear requirements for validation include detailed specifications of the expected output or results and the necessary resources, whether humans or machines.

For instance, in a development process, clear requirements would specify the development outcomes. In addition, the stipulated inputs for the process should also be included.

They serve as the basis against which the validation process can be conducted to ensure that the intended results are achieved.

Clear requirements also help ensure a successful validation process by providing a clear roadmap.

They offer objective evidence that a process consistently produces a result meeting its predetermined specifications.

On the other hand, the potential consequences of not having clear validation requirements could include a lack of clarity on the processes, inputs, and expected outcomes, leading to improper validation.

This could ultimately result in the delivery of substandard outputs or products, indicating a lack of process consistency and non-compliance with predetermined specifications.

Step 3: Making the Validation Protocol

Planning Your Test Steps

Validation process planning involves specific steps. These steps include defining key activities like formal proof of properties from upper-level requirements and safety studies and functional tests based on the next level’s specification. Thorough planning is vital to address critical aspects of the validation process.

Test instructions for effective validation testing should be clear and detailed to reduce the number of tests. These instructions should be designed to verify fitness between modules and safety requirements, using existing tools and resources for validation.

When planning to record and report test results, it’s important to structure documentation practically. This ensures accurate recording and reporting of evidence from formal proof, functional tests, and property verifications. Utilizing resources like the Design Verifier toolkit can facilitate the software development process.

Thorough planning and adequate documentation ensure the validation process efficiently provides objective evidence of fulfilling a specific intended use or application.

Writing Test Instructions

Test instructions must be clear and easy for users to understand. Consider the user’s familiarity with the procedures. Use simple, consistent language and formatting for all users. Practical illustrations, diagrams, or real-world examples can help users understand the steps. Highlight special considerations or precautions prominently. Include real-world examples to illustrate potential errors or important steps.

State-specific tests need to be conducted in order to provide real-life scenarios highlighting their importance.

Step 4: Running the Tests

Doing the Tests Correctly

During the validation process, it’s essential to follow specific verification processes. These include design verification and formal proof of properties from upper-level requirements. Functional tests based on the next-level specification are also crucial.

To ensure accuracy and integrity, test instructions should be clear and precise. They must include step-by-step guidelines for test performance and specific criteria for a successful test. Recording test results accurately and transparently, including documenting any observed issues, is essential.

Best practices for recording test results involve using a standardized format, proper labeling, and organization. Ensure secure storage of results, especially in safety-critical applications. This maintains the validation process’s reliability.

Recording Test Results

When recording test results, it is important to include the date and time of the test, the name of the tester, and detailed descriptions of the procedure and results to ensure accuracy and traceability.

Additionally, any relevant environmental conditions, such as temperature or humidity, should be documented to provide context for the test results.

To meet regulatory requirements and internal standards, the recorded test results should include information on the validation process used, including the verification of properties, formal proof of properties, and functional tests based on the specification of the next level. Any deviations from expected outcomes and corrective actions should also be documented.

Test results can be organized and documented to facilitate analysis and decision-making by using the SCADE environment’s property verifier to develop a specific board that instantiates model M and observer O associated with property P. The validation phase by proof is expected to reduce the number of tests performed. Moreover, a certification code generator and strong typing can be used to facilitate modular testing and reduce the scope of the tests. These details are crucial in offering comprehensive and meaningful insights to stakeholders who must make informed decisions.

Step 5: Finishing Up With Procedures and Reports

Updating Procedures After Testing

The Validation process application helps update procedures after testing. It incorporates identified changes or improvements.

The Design Verifier (DV) toolkit contributes to detecting errors in the early stages of development. This reduces the risk of errors during the final validation phases as part of the formal proof process.

Modular testing and a certified code generator significantly decrease the scope of tests. They verify the fitness between modules and safety requirements.

If proof fails due to a lack of information in imported code, the team can isolate the component and introduce assertions characterizing the imported component for complementary testing.

Using objective evidence to ensure compliance with upper-level requirements and for safety studies, all changes to procedures can be fully documented and communicated.

The final validation report accurately captures the testing process and outcomes. It ascertains that the development outcomes meet the requirements and that the product to be sterilized is indeed sterile in compliance with the FDA’s definition of process validation.

Making the Final Validation Report

The final validation report summarizes test results and findings. It includes the specific test methods, observed outcomes, and any discrepancies found. The report also analyzes the data, highlighting notable trends, patterns, or anomalies. It presents conclusions and recommendations from the validation process so that stakeholders can understand the results.

To ensure completeness and accuracy, the report should include a detailed validation protocol description, specific acceptance criteria, a summary of all test results, including successful and failed tests, and an analysis of potential risk factors or limitations observed.

Additionally, it should outline any deviations from standard protocols, their justifications, and any corrective actions taken.

The report should be structured clearly and straightforwardly, with distinct sections like an executive summary, a detailed description of validation methods, an analysis of test results, and a summary of conclusions and recommendations. Visual aids like tables, graphs, or diagrams can help illustrate key findings and trends for easier understanding.