Preclinical (GxP) Validation
Do you have GxP compliant audit logs?PathcoreFlow
Applies to: PathcoreFlow
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.
Do you have the ability to track the reason for change as part of the auditing framework?PathcoreFlow
Applies to: PathcoreFlow
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.
How do you deploy updates in GxP validated environments?PathcoreFlow
Applies to: PathcoreFlow
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.
Are updates cumulative?PathcoreFlow
Applies to: PathcoreFlow
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.
How long does it take to validate Pathcore software for GxP environments?PathcoreFlow
Applies to: PathcoreFlow
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.
Do you offer an environment for validating updates before accepting them?PathcoreFlow
Applies to: PathcoreFlow
Yes. Access to an environment suitable for acceptance testing is included with the "Dedicated validation environment" add-on for PathcoreFlow.
When is the validation environment updated to the latest release?PathcoreFlow
Applies to: PathcoreFlow
Pathcore's dedicated validation environment receives the most recent PathcoreFlow updates as soon as they are available, so you may begin validation immediately upon announcement of a new version.