The Validation procedure for the new machine consists of the following elements: installation qualification, operational qualification, and performance qualification. The purpose of the validation is to prove that the new machine works correctly and provide accurate and expected results. Installation qualification confirms that the exact required equipment has been received and installed, in the correct design or format in undamaged form with parts, spare parts, gauges, and other necessary elements. Operational qualification ensures that the installed equipment will function in accordance with all its operational specifications in the specified environmental conditions. Performance qualification ensures that the installed equipment consistently performs its functions in accordance with the specification corresponding to its daily/routine use.
For each validation, you need to have a validation plan and validation report. Validation report must have the following elements:
It must identify the impact of each piece of equipment on the product
Identifiy the risk that equipment have on the final product
Document which SOPs are used, calibration equipment, etc.
Have to have all criteria defined what is acceptable and what is not
All test results that were performed during the validation process<
Photos are always a good way of proving that you have performed something – like a photo of the screen on the equipment that reflects the conditions of the process and so on