Aiding Customers with 21CFR Part 11 Compliance

A new version of software for Crescent Design's HBLT (Hydraulic Burst Leak Tester) is now available. This version supports an optional 2D barcode scanner and adapter. Using this scanner, a test can be loaded into the HBLT from a 2D barcode printed or displayed on a computer screen.

Once developed on an HBLT and validated, a test can be transmitted to CDI's new ScanTest software tool that runs under Microsoft Windows. This tool generates HBLT-compliant 2D barcodes, which can be saved for use with lot travellers, or whatever production system is preferred.

This new feature eliminates the risk of a test stored in the HBLT being altered by unauthorized persons. Also, an operator would not be able to select an incorrect test.

Optionally, test results can be transmitted to a secure data management system that complies with 21CFR Part 11 requirements.

Another new feature allows an operator to reset the zero pressure (tare) to compensate for small zero-pressure shifts in the pressure measurement system.

Please contact sales at Crescent Design for details.