A successful validation process will ensure that each requirement for a use is fulfilled, essentially end user needs are met. An important aspect of a validation plan is knowing your target customer/end user so that you can confirm that the needs they have are met. In addition to this there are multi functional teams that are responsible for the validation process as package integrity tests are conducted ranging from temperature excursion, humidity, shock/vibration, corrosive environments, shipping lane validations, and altitude. These factors can all influence the final product and therefore need to be characterized and documented for validating product.