Geneious Prime is for research purposes only. It is not validated for clinical work - responsibility lies with the end user for any relevant compliance.
Note that Geneious has been awarded the International Organization for Standardization (ISO) 27001:2013 certification for our security practices.
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:
- Geneious Cloud can be used to store your data on our secure cloud platform where permissions can be used to control who has access to each project.
- 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” section 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".
ISO 27001 Certification
We have been awarded the International Organization for Standardization (ISO) 27001:2013 certification by Schellman, following an external review of our Information Security Management System (ISMS).
In order to achieve ISO 27001 certification, a company must show it has a systematic and ongoing approach to managing information security risks that affect the confidentiality, integrity, and availability of company and customer information. The standard emphasizes the measurement and evaluation of an organization’s Information Security Management System (ISMS).
During the external audit, Schellman assessed the ISMS, which applies to Biomatters and Geneious Biologics operations and support, software development and cloud hosting, and found that we meet or exceed the standard in all areas. The auditor concluded that controls had been put in place to protect information assets against associated risks, and that these controls were being monitored and managed effectively.