ABSTRACT

Title page Purpose: state what the report contains or what validation has been successfully completed. Scope: state the range of the project and any history or supportive testing performed prior to initiation of the validation. Responsibilities: define in the protocol and do not repeat in the report. Equipmentlmaterials: define in the protocol and do not repeat in the report unless additional supplies and equipment were used. Procedure: outline in detail the steps that were followed. If any deviations occurred, be sure to discuss them and the results. If changes to the protocol were required during the validation, the approved and signed Addendum should be included in the report. Results: discuss the results from the dose verification experiment and determine if the results comply with the acceptance criteria defined in the protocol. Any rationale used to repeat the experiment or augment the dose must be documented. Conclusion: state whether the data met the acceptance criteria. Discuss any deviations and any rationale for rejecting any dose experiments or test results.