Here are the features and company practices that Tulip uses to comply with GxP regulations.
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.
Internal Practices
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.
GxP Specifics
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.
Access Control
Tulip has multiple user roles that allow for different levels of access to Tulip and the Tulip Player.
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.
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.
Approvals
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.
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 Digital Record History in an app.
Good X Practice. An abbreviation collecting many of the core principles of Life Sciences compliance.
ex-
GMP - Good Manufacturing Practice
GLP - Good Laboratory Practice
GDP - Good Distribution Practice
GxP
Good X Practice. An abbreviation collecting many of the core principles of Life Sciences compliance.
ex-
GMP - Good Manufacturing Practice
GLP - Good Laboratory Practice
GDP - Good Distribution Practice
Tulip Player
Tulip Player is the Windows/Mac executable program where users can run Tulip apps. Tulip player allows you to create a more seamless user experience by removing the need for a web browser, and allows increased IT controls.
Station
Stations are a digital representation of a physical place or device in your facility. Stations are 1:1 with Devices running Tulip Player, but Stations can also be assigned Edge Devices, Tulip Vision Camera Configurations, Machines,and more.
Display Device
Users interact with Tulip applications through physical interfaces like touchscreens, PC monitors, mobile devices, and LCD screens. We refer to these interfaces as display devices. Display devices are always paired with a station during the application publication process.
Tulip Player
Tulip Player is the Windows/Mac executable program where users can run Tulip apps. Tulip player allows you to create a more seamless user experience by removing the need for a web browser, and allows increased IT controls.
App Completion
App Completions are a mechanism to store immutable data from a Tulip app. When an app is completed, all Variable's current values will be stored in the app completions tab.This completion data can be analyzed in Analytics.
By default, after a Completion users will be brought back to the Begin Screen of your application. This behavior can be adjusted with other Transition types.
Published Version
The Published Version of a Tulip app is a complete version of your Application. When an app is ready to be run in production, its logic can be frozen by Publishing that app. One application can have multiple published versions. If a Station is assigned to run the Published version of an application, it will only see changes when they are published.
Station
Stations are a digital representation of a physical place or device in your facility. Stations are 1:1 with Devices running Tulip Player, but Stations can also be assigned Edge Devices, Tulip Vision Camera Configurations, Machines,and more.
Tulip Player
Tulip Player is the Windows/Mac executable program where users can run Tulip apps. Tulip player allows you to create a more seamless user experience by removing the need for a web browser and allows increased IT controls.
Table Record
A Table Record is a reference to a row in a Tulip Table. Table Records can be created either from the Table UI or from with an App Trigger.
To edit a record it must be loaded into a Table Record Placeholder.
Digital Record History Widget
The DRH Widget allows users to review the changes that have occurred to a Record. Traceability to changes is critical in a GxP Environment.
Electronic Signatures
In regulated environments (GxP) getting a user signature to the accuracy of data is critical for process validation. The E-Sig Widget allows users to collect user signatures along with associated metadata.
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