Preclinical (GxP) Validation

Yes. The activity logs, as we call them, track changes made to the Repository and can be used within a GLP compliant environment. Activity logs provide details including who has made the change, when the change was made, what has changed and optionally, why the change was made.

Yes. Reason for change can be enabled by policy for specific folders and actions. As a result, it becomes possible to conduct regulated and unregulated studies simultaneously within the same platform.

We notify our customers of available updates and give each of them the opportunity to weigh the benefits of receiving vs skipping it. This is particularly important for GxP scenarios when validation may need to be performed for each update received.

In GxP validated environments, some customers choose to have multiple deployments of PathcoreFlow, such as isolated production and testing environments. In these cases, the testing environment is used to validate updates before these are accepted in the production environment. In some cases, customers will even utilize a third environment for internal development work, such as developing integrations, experimenting with the API, and conducting other experimental tasks, without undermining their testing and production environments.

Yes, updates are cumulative. This means each update includes all previously released updates. If some updates are skipped, the next accepted update will include all of the previously released changes.

This really depends on the needs of each customer, and we support them to meet their GxP requirements. We offer an immersive post-sale support program, IQ/OQ validation reports, dedicated validation environment for acceptance testing, and a Customer Success Program that is designed to support customers with these and other technical or workflow processes.