How do you perform design verification and validation for your product?

1 What is design verification?

Design verification is the process of confirming that the design outputs meet the design inputs. Design inputs are the requirements and specifications that define the intended use, performance, safety, and reliability of the product. Design outputs are the results of the design activities, such as drawings, models, prototypes, test data, and documentation. Design verification ensures that the product is built right, according to the design inputs.

2 What is design validation?

Design validation is the process of demonstrating that the product meets the user needs and intended use in the actual or simulated operating environment. Design validation confirms that the product does what it is supposed to do, and that it is safe and effective for the end user. Design validation may involve clinical trials, user testing, field testing, or other methods of evaluation.

3 How to perform design verification?

To perform design verification, you need to establish verification plans and procedures that define the methods, criteria, and acceptance standards for verifying the design outputs. Additionally, you should document any discrepancies or nonconformities and corrective actions taken. Examples of design verification methods include testing to measure performance or functionality, inspecting visually or with instruments, analyzing with mathematical or engineering principles, and reviewing with design inputs, standards, or best practices. Doing so will help ensure the completeness, accuracy, and adequacy of the design.

4 How to perform design validation?

To perform design validation, you need to establish validation plans and procedures that define the methods, objectives, and criteria for validating the product in the intended use environment. This includes conducting clinical trials to assess safety and efficacy, collecting feedback from potential users via user testing, deploying the product in a real or simulated operating environment for field testing, and identifying and assessing potential hazards through risk analysis. Additionally, you must document the validation results and any corrective actions taken to address any issues or failures. Doing so will help ensure the product meets the required standards.

5 Why are design verification and validation important for GMP compliance?

Design verification and validation are essential for GMP compliance because they guarantee that the product meets regulatory requirements and customer expectations. Additionally, they help to avert or detect any defects, errors, or problems that may affect the quality, safety, or effectiveness of the product. By performing design verification and validation, you can prove that your product conforms to the specifications and standards established by the authorities and industry. This also provides evidence that your product is suitable and safe for its intended use and user group. Moreover, it reduces the risk of recalls, complaints, or legal actions due to faulty or harmful products while improving the efficiency, productivity, and profitability of your product development and design process.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?