July 2023, MARIETTA, GA ~ The software package meets the needs of pharma industry customers for operating solutions that comply with Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP) guidelines. The software also meets CFR 21 Part 11 demands for full security and traceability of data and electronic records and cGMP requirements for full Audit Trail functionality.

Advanced HMI features:

The GPX HMI software package supports all Gasporox Instruments, such as the GPX 1500 series of vial and film testers, and its VialArch™ and other sensor modules that can be installed on production lines for CCIT container closure integrity testing.

The software manages all data in an SQL database as electronic records, with full recording of traceable datasets to meet the CFR21 Part 11 guidelines on compliant electronic records. The HMI software also features configurable user management with three levels of access privileges, along with recipe management with automatic versioning and traceability within batch reports that also include batch summary, audit trail and measurement data as protected pdf files.

The GPX HMI forms a valuable and highly accessible supplement to the existing Excel®-based Gasporox Report Generator software, but with significantly greater functionality for batch handling and reporting, recipe management and Audit Trail functionality

Complete solution:

Gasporox Senior Application and Sales Manager Roland Koch commented: “Our development of the GPX HMI meets latest pharmaceutical regulations that require GMP compliant software tools for Electronic Records and Electronic Signatures.” “We were also seeing increasing industry demand for a complete solution from Gasporox: one that would include one stop supply, easy implementation of the software with no extra interface or other software needed and just a single supplier involved for the whole application. These features all reduce integration time and cost,” said Mr. Koch. To learn more click here

Benefits:

• GMP compliant

• MySQL database

• Same software package for the GPX1500 Instrument series and the VialArch™

• Important features to consider when selecting a stability chamber

• 21 CFR Part 11 compliant & Protected pdf Batch Reports

To receive more information, please e-mail sales@flwse.com