When a deviation from the Validation Plan occurs, what is required in the Validation Report?

In the context of the Validation Report, a clear explanation of any deviations from the Validation Plan is essential. It provides transparency and clarity regarding what aspects of the original validation protocol were not followed and why those changes occurred. This explanation is critical because it helps stakeholders understand the implications of the deviation on the validity and reliability of the validation process and the results obtained. It allows for an assessment of potential impacts on data quality and assists in determining whether additional action or adjustments are necessary to maintain compliance and integrity in the laboratory's processes.

Providing a detailed account of deviations ensures that any potential risks are acknowledged and managed appropriately. It serves as a reference for any subsequent evaluations and can inform future validation efforts to avoid similar issues. Without this clear explanation, there could be confusion or misinterpretation of the validation findings, potentially compromising the laboratory’s quality assurance practices.