A Summary of Tulip's GxP Capabilities
- 21 Dec 2022
- 5 Minutes to read
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A Summary of Tulip's GxP Capabilities
- Updated on 21 Dec 2022
- 5 Minutes to read
- Contributors
- Print
Article Summary
A Summary of Tulip's GxP Capabilities
Here are the features and company practices that Tulip uses to comply with GxP regulations. This feature is only available on "Enterprise" plans.NOTE
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.
Learn more about user roles in Tulip
Learn more about 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.
Version Control
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.
Learn more about app completions in Tulip
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 Editor.
Read more about publishing versions
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.
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.
Audit Log
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.
Read more about Activity History
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.
Read more about the Record History widget
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.
Read more about permissions at an app level
Electronic Signature for Operators
Tulip allows operators to sign within apps using e-signatures to certify that they have completed the app.
Further Reading
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