APPLICATION MODErNIZATION – PHARMACEUTICAL

Global pharmaceutical manufacturer launches next-gen clinical testing solution

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Overview

The pharmaceutical industry relies on precise, finely configured equipment.

It uses diagnostics and clinical testing instruments to produce medicine that is safe, effective and compliant with FDA regulations. That precision and accuracy extends to the software and communication layers that dictate how this machinery operates.

One of our clients in the pharmaceutical space recently approached One Six Solutions with an ambitious project: help develop the architecture and underlying software for its new next-generation diagnostics and clinical testing equipment, including writing the entire communication layer.

With our industry experience and software engineering expertise, we were able to produce a solution that can connect with external systems, transmit relevant data and meet requisite compliance demands.

The precision and accuracy extends to the software and communication layers that dictate how this machinery operates.

Our Solution

The pharmaceutical industry relies on precise, finely configured equipment.

Any software development project in the healthcare or pharmaceutical fields needs to account for industry regulations. In this case, the platform needed to pass an FDA certification process, as well as use industry-specific protocols to transmit data.

Our team built the communication layer with those demands in mind, supporting Health Level 7 (HL7) and other healthcare protocols. During the development process, we diligently documented every code review, software test and bug to submit to the FDA, per the agency’s requirements. One Six Solutions software developers also collaborated with our client’s internal teams on the platform’s design and various quality assurance tasks.

We took advantage of the latest technology to help build a sophisticated application that met our client’s extensive needs:

  • The application was built in Windows Communication Framework.
  • Windows Presentation Framework served as the front-end interface.
  • Google Protocol Buffers, HL7 and ASTM protocols facilitated communication with back-end third-party systems.
  • The database access layer was written using LLBLGen Pro.
  • Unit tests were created in NUnit and Moq.
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The Results

The finished clinical testing device can successfully communicate with a variety of third-party machines and platforms and is in the final stages of FDA certification.

While One Six Solutions has completed initial work on this project, there is still plenty more to do. We are hard at work developing additional post-launch features to expand integration capabilities.