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A Michigan based Fortune 500 company and leader in medical device technologies initiated a project to upgrade their existing Axeda® system application to the latest software version. Axeda®, recognized as a front-runner in machine-to-machine (M2M) technology on the Internet of Things (IoT) environment, offers a highly customizable software package with user interface, expression rules, and two-way communication with assets, tracking, and editor capabilities. The medical device company’s application monitors and collects real-time data from the suite of deployed instruments interfaced to the system, and then manages the data to generate usage statistics used in predictive maintenance and rapid response to events. This medical device company contracted Performance Validation to validate their upgraded system.
The Challenge
Performance Validation was contracted to develop life cycle documents and test protocols that would not only satisfy the validation requirements of the current project but would also provide a scalable and repeatable documentation model for future expansion of the client’s Axeda® system.
Development and testing were conducted in four system environments.
- A “sandbox” environment was established by the client to allow testing of the new version without disrupting product development. Initially, this environment was installed with the existing version of Axeda® system software and protocols were written and executed to verify this version of the system application. The environment was then upgraded to the new version of Axeda® system software.
- A Quality Assurance (QA) environment was established as the functional equivalent of Production. This is where the main body of validation testing was executed.
- The standing Production environment was upgraded to the new Axeda® Platform version following successful completion and approval of thorough testing in the QA environment. This environment was subjected to a somewhat scaled back set of scripts which including Installation Qualification and core functionality testing.
- The Development environment for prototyping only.
Performance Validation collaborated with the client’s business analyst to document all of the customizations for the current system in a Configuration Design Specification document. Then, all of the new configurations related to the upgrade were incorporated. This document, in tandem with the Requirements document served as the basis for the test protocols.
The protocols identified in the testing strategy by the Performance Validation employee were executed in both the QA and Production environments–application installation qualifications (AIQs) and data integrity tests were executed first. The remaining operational, security, assets, audit trail and password, user groups, reports, and external applications were subjected to operational and performance qualifications.
The PV Advantage
The PV team member on this project has 15 years’ experience in CGMP environments. The team member provided valuable expertise in addition to the development of the validation deliverables. PV’s proximity to the customer site meant being able to provide on-site and off-site support throughout the project as befit the customer.
The Results and Benefits
The Design and Configuration Document now includes all customized configuration elements used in the Axeda® application. The next generation of devices is to have more information available for personalized (to the specific organizations) predictive analytics. As the firm’s goal is to have all devices connected and providing machine and sensor data. Their Axeda Project Team has a set of validation documents to serve as a basis for future upgrades and that can be leveraged for other connected care projects.
References:
Axeda®
For more information, please, schedule a call with one of our subject matter experts.
Kevin Marcial,
Senior Validation Engineer
Performance Validation, LLC.
