What is the maximum number of users allowed within the system of UDiBar?

UDiBar provides one dedicated Administrator account for system control and approval management.

There is no limit on the number of "User" or "Super User" accounts. A single license can therefore support unlimited users, enabling multiple team members across different workstations within the same local network to collaborate under one centralized UDI database. This structure maintains control through the Administrator role while providing scalability for growing teams.

Which user has the authority to change or modify label information?

Super user and user.

Is UDiBar installed locally or hosted externally?

Installed locally.

Is the software compatible with all types of printers? Are there any specific models required/restrictions?

UDiBar supports printing through the standard Windows printer driver, allowing compatibility with most printers recognized by the Windows operating system.

In addition, UDiBar provides native driver support for the following industrial label printer brands:

  • Argox
  • Domino
  • Zebra

These native drivers enable more precise control and optimized performance for label printing. Other printer models can still be used via the Windows universal driver, ensuring flexibility while maintaining broad hardware compatibility.

What languages are supported by the software interface? English, Traditional Chinese and Simplified Chinese.

English, Traditional Chinese and Simplified Chinese.

Does UDiBar include an audit trail for labels to track modifications?

Yes. You may check the label history to track who and what modifications were made.

Can the system help to identify who printed a label on a specific day? Is action history recorded?

Yes. UDiBar records the complete printing history for every label. Through the inquiry function, you can review all printing records, including:

  • Who performed the print
  • When the label was printed (date and time)

 

This provides full auditability and supports traceability requirements under ISO 13485 and regulatory inspections. Does UDiBar comply with Regulation 2017/745?

UDiBar facilitates compliance with MDR 2017/745 UDI requirements by providing functions such as UDI coding, label design/printing with traceability audit trails, and managing audit history—features that help manufacturers meet MDR expectations.

The compliance obligation under MDR ultimately falls on the medical device manufacturer, not the software vendor. The manufacturer must demonstrate that their tooling and processes satisfy MDR's UDI requirements as part of their technical documentation.

Does WhaleTeq provide documents for validation?

Yes, WhaleTeq provides the software V&V report for UDiBar.

What is the procedure for UDiBar software implementation? How does it work?

UDI Coding -> UDI Label Design -> UDI Label Printing -> UDI Label Inspection

This closed-loop workflow ensures that every step—from data creation to physical label output—is controlled, auditable, and compliant with ISO 13485 and UDI regulations, minimizing human error while maintaining full traceability.