As many of you know, when you get hired as an engineer the first couple of weeks are dedicated to being trained per the SOP’s of the company. Therefore, as a startup company, the employees will learn the standards of the company through SOP documentation. There are general guidelines on how to go about the validation and verification process which can be found online. But an employee will need to implement those guidelines in the companies Quality System documentation for it to be used within the company. Safety should be placed as a high priority when validating a device because if an auditor comes and finds errors in the company’s validation of a device it can escalate into a major issue for the company itself. Any equipment requiring a validation also requires a specification document, an IQ/OQ/PQ based on the device and protocol as the bare minimum.