GLP 21 CFR 11 Compliance Checklist

GLP 21 CFR 11 Compliance Checklist

This article will contain useful information regarding GLP 21 CFR 11 compliance while working with Cubis systems.

If you’re working with a system in your lab involving Cubis technology, you have come to the right spot. This article will contain useful information regarding GLP 21 CFR 11 compliance while working with Cubis systems. Read on to learn more!

Subpart B – Electronic Records and 11.10 Controls for Any Closed Systems

Sartorius has structurally validated the Cubis II MCA software, like the firmware and QApp packages. So the application is validated. You might wonder, does its validation documentation show that Part 11 requirements have been fully met and are working correctly? The answer to this is yes. The Cubis II MCA software allows customers to comply with 21 CFR Part 11. Still, compliance can occur only if the QApp package pharma is licensed and the application’s user management, electronic signature, and audit trail are all used. Validation documentation is available for examination during the audit of the Sartorius quality system for all product development.

Is it Possible to View the Whole Contents of Electronic Records?

Yes, it is entirely possible to view the contents of electronic records for GLP. Settings and other modifications of settings are recorded in the audit trail. The audit trail could be filtered and sorted out for review. System information, warnings, and messages are recorded in the Status Center message archive while weighing results are documented within the alibi memory. The alibi memory is capable of being filtered by ID or date.

Is There a Secure and Computer Generated Time Stamp Audit Trail that Records the Time and Date of Operator Entries and Actions that Modify, Create, or Delete Electronic Records?

Yes, all actions and entries that create electronic records are tracked with a username, time, and date stamps traceable to UTC. The created records are grouped into categories depending on which function is affected. The modification of the system and task settings, the installation of tasks, and the uninstallation of tasks are also tracked. The audit trail function can’t be switched off, and the system will not allow you to modify or delete any records.

Accidentally acquired weight values can be set to invalid by a user and a reason to be entered. The invalidation and cause are then recorded in the audit trail. Users can’t delete the acquired weight values.

To learn more about Cubis II MCA 21 CFR compliance with Cubis systems, give the Lab People a call today!


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This entry was posted on Friday, February 17th, 2023 at 12:09 pm. Both comments and pings are currently closed.

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