Note: This feature is only available on "Enterprise" plans.
Tulip works with customers in the life sciences industries. Therefore, we offer a special version of our cloud software that was developed according to the GAMP 5 framework under a QMS compliant with ISO 9001:2015.
Here is how Tulip complies with typical GxP standards.
Tulip uses a QMS that was designed in compliance with ISO 9001:2015.
Tulip offers an LTS, or long term support, release to support the needs of regulated customers. This is released every 6 months.
Tulip uses the term "GxP Mode" to describe the version of its cloud software that is used by customers with GxP requirements.
Here are our practices around different software features required for GxP compliance.
Tulip has multiple user roles that allow for different levels of access to Tulip and the Tulip Player.
Running Apps on the Shop Floor
Stations can only run apps on one Display Device at a time. A device running the Tulip Player automatically logs out when it is transferred away from a Station.
The Tulip Player will automatically logout and cancel any running app after a customizable number of minutes of inactivity (but there will be a warning). This can be disabled upon request.
All apps in Tulip are version controlled. When an app is executed in the Tulip Player, the version number of the app is logged alongside all other app data with each completion.
You can only run "Published Versions" of Apps on Stations. If you'd like to run a non-published version, you need to click "Run" from the App Builder.
Your organization can define which users are allowed to publish specific apps.
After the app is published, the Tulip Player at the operator’s workstation will open the latest published version of the app upon the next time that the app is restarted, completed or cancelled.
The Approvals feature allows you to define which Tulip users are required to review a new version of an app before it can be used on the shop floor. Only users with the "Account Owner" role can modify Approvals.
The latest version of the app must be signed electronically by all approvers before it is published and made available to be used by operators.
Apps and Users have unique IDs associated with them.
All Activity History will include this information (and can be exported as PDF)
Dates are more explicit in Activity History. Each timestamp is included as text.
Tulip also provides an audit log for each individual Table Record, which is used to store information about a single batch, material or subassembly. This is displayed in the record history widget in an app.
App Building Permissions
By default, only the app creator can edit an app after they create it. They can give permissions to others to edit the app if needed.
E-signatures for Operators
Tulip allows operators to sign within apps using e-signatures to certify that they have completed the app.