Checklist for Auditing Sterilization with Radiation Mobile App

Every audit requirement should be evaluated separately. This checklist shall be used for assessment of operators of the corresponding sterilization facilities. Where sterile products are to be included in the company’s product spectrum, a sterilization assessment (including assessment of design and validation of sterilization processes) must be carried out based on at least one product file of a sterile product. For sterile products of risk class III, the documentation of design and validation must be examined. Where an assessment of sterilization procedures validation is necessary as a part of the QM assessment for medical products, the present checklist should be applied in case of radiation used as the sterilizing agent.