Activity

  • According to ‘Bonezone Article – Design Verification – Validation File’, and FDA definition for Verification ‘ Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled’

    So, Why do you think Verification is important ? and Your ideas to improve Verification process in a design control ?

    For Example:
    I think Good verification practice minimize commercial risks, risk to users and the cost of satisfying regulatory requirements. Also, poor verification practice can cause (for example) FDA recalls and user injuries and deaths.
    Example to improve Verification:Do Early verification!, that will help you to learn about the properties of
    the device and will help you to identify design problems early in the design process and therefore reduce rework.
    Your thoughts ?