Disable Axion Annotation Modifications
Implement a configuration setting (system-wide mode) that fully disables Axion annotation modifications for all users. This setting must prevent any form of annotation changes—including deletions, edits, and updates—to ensure records remain immutable. If you need to "Cancel" an annotation, the user needs to create a new annotation noting that the previous annotation is no longer true. The purpose of this control is to support compliance with State regulations requiring preservation of original annotations without alteration.
2 replies
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The requirement that annotations cannot be altered is found in PMO (Pasteurized Milk Ordinance) 2023 , Appendix H, Section V, Item 12.
Specifically, this item states:
"12. The electronic computerized data collection, storage, and reporting system shall not allow for the alteration of the data and/or the annotations."
This section ensures the integrity of the electronic records by prohibiting any changes to the collected data or the operator notes (annotations) once they are entered into the system. This aligns with the WORM (Write Once, Read Many) requirement.
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https://www.fda.gov/media/180975/download (page 264 of the PMO, page 288 of pdf doc)
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