Deviation Impact Assessment

Equipment: Weighing Balance (Analytical/Platform)

[Enter detailed description of the deviation here, including date of occurrence, nature of the deviation, and any immediate actions taken.]

[Classify the deviation based on its impact, e.g., Major, Minor, Critical.]

[Describe how the deviation may impact the product or patient safety, including any potential risks.]

[Assess the impact of the deviation on data integrity, including any compromised data and its significance.]

[List all affected batches or studies, including batch numbers and study identifiers.]

[Outline the investigation process, including who conducted it, methodologies used, and findings.]

[Detail the CAPA plan, including actions taken to correct the deviation and prevent recurrence.]

[Provide the decision regarding re-testing or re-qualification of the equipment, including rationale.]

[Document the QA disposition regarding the affected products, including any decisions made about release or destruction.]