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LiveWorx 2017

Delivering with Integrity – A Case Study in the Development of Safety-Critical Products

Session Description

The Hybrid Closed Loop pump software was the first project developed and delivered using the ALM tool PTC Integrity. The system allows the automatic adjustment of insulin delivered to the patient. The case study will present both the development of the solution tailored to fit the software development needs and the application of the solution to the project. The design and use of items to manage changes and the general workflow for document changes, Tests, and test results reporting. It will discuss the architectural decisions made in modifying the Integrity solution. The workflows not only guide and constrain users; they provide a uniform way to generate the work products. I will discuss the main elements of our solution, some of the supporting Items, and discuss the decisions that went into the development. The main items covered are: Document control Change Control Defect Tracking Traceability Test Execution recording Report Generation Workflow support

Session Presenter
Additional Information
Data Management
Healthcare & Medical Devices
Consistent workflows and the ability to link together many different data allowed the accurate and efficient generation of documentation for submission
Having the data in a single database facilitated the ability to gather many different data parts and render it in a single report.
Don’t over engineer your processes, we are trying to simplify some of the items and triggers to better support the team.
Case Study
45 minutes
Session Schedule