Has Geneious Prime been validated? Does it comply with the FDA regulation 21 CFR Part 11?

Geneious Prime is for research purposes only and is not validated against any published standards. Responsibility lies with the end user for any relevant compliance.

Accuracy of Results

We take pride in the quality of Geneious software and we take reasonable steps to uphold the accuracy of the results it produces. However, we cannot guarantee correctness in all circumstances. We encourage users who require a high degree of confidence in results to perform their own validation using tools, data and parameters that are as close as possible to what will be used "in production".

If you discover any issues with the accuracy of results produced by Geneious, please tell us, as we take such issues very seriously.

Auditing and Data Integrity

The integrity of data stored within Geneious Prime cannot be guaranteed. However, Geneious Prime does provide functionality that can be used to increase data integrity:

    • The Shared Database allows storage of data on a centralized SQL server where it can be backed up, encrypted, monitored and be under access controls. In addition, a license can be purchased for Geneious Server Database which provides, amongst other things, a layer of security between client and server as well as an audit log for changes to access controls.
    • The History tab (under the Info tab) on all documents provides a record of who made changes to each document and when. Geneious also records who created/last edited each annotation and keeps track of operations performed on documents with lineage tracking (parent/descendant tracking).
    • Advanced administration features allow pre-setting/locking of certain functionality and settings throughout the software to ensure appropriate tools/settings are used. See “Advanced Administration” chapter in the Geneious Manual for further information. 

Validation Documents

We do not have any specific documents available that would assist you in producing your own validating documentation. We recommend documenting your own validation with a specific version of Geneious Prime using tools, data and parameters that are as close as possible to what will be used "in production".

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