GEX Corporation: COMPLIANCE & AUDITING application

GEX Corporation provides high quality dosimetry-related products & customer service for the radiation processing industry worldwide. Their software & hardware facilitate FDA compliance for the process of cleaning medical equipment using radiation. The team at Dev IQ built a measurement & reporting application that interacts with radiation measurement hardware.

Challenge

DevIQ was tasked with replacing an Excel/Windows XP program in use for over 15 years in a highly regulated, offline environment. The new solution would have to meet both GEX and their customers’ demands: Electronic storage, data exchange, customizations, and compliance with 21 CFR Part 11 FDA data retention and auditing. To reduce GEX team’s support costs, the new application would need to allow for seamless updates and customer specific configurations within a single code base. This particular challenge constrained the team from using common web technologies for deployment and support.

Solution

The Dev IQ team built DoseControl®, a desktop application that connects to multiple hardware peripherals, provides custom dosimetry report templates, and exposes multiple data storage and exchange configurations. It supports multiple calibrations and dosimeters. The Microsoft WCF Windows application framework, including Microsoft.NET, allowed Dev IQ to build an application install package that can be easily deployed to an internet-less world. With each version released, the update package contains all of the information to migrate the application and database to the latest version without manual user or technical intervention. GEX Corporation’s customers are confident their data is safe and validated for future audits. The development team leverages automated unit and integration tests to ensure new features and improvements reduce the risk of bugs into the data calculations and data retention process.

Features & Technologies

DoseControl® is a highly configurable system to manage dosimetry workflow from measurement to auditing. In conjunction with its custom hardware components and dosimeter line of business, GEX’s scalable and modular software design can adapt to almost any routine industrial dosimetry application, while decreasing maintenance and support time for GEX staff. 

  • Hardware plug and play: Supports 3 Thermo-Fisher Scientific spectrophotometer models, 3 different barcode scanners, and Metralight laser micrometers.
  • Several configurable user management modules, including LDAP.
  • Oracle and Microsoft SQL server compatible.
  • Custom PDF reporting modules.
  • Granular auditing trail from user login to dosimeter measurement to report completion.
  • Supports Oracle and Microsoft SQL
  • Microsoft Windows Presentation Foundation (WPF) framework using C#
  • Serial port and USB peripheral enabled

Result

GEX Corporation has reduced support costs by deploying a single installed app to their diverse clientele around the world. The support team can provide updates to their end users with a validated upgrade package in the diverse, disconnected world of dosimetry measurement. Their end users can confidently provide on-demand auditable reports and data access to the FDA and international compliance agencies. DevIQ built an application that will allow GEX corporation to continue their growth into the next 15 years by removing the complexities of supporting customer specific configurations and installs.

Learn more about DoseControl® in GEX Corporation’s website:

http://www.gexcorporation.com

http://www.gexcorporation.com/dosecontrol.html

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