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Implementing Agile in an FDA-regulated Environment While many industries have adopted agile, the medical device industry, which develops products for life-critical applications-where quality and reliability are clearly a top-priority, remains largely stuck under the “waterfall.” Medical device firms must comply with FDA regulations that overwhelmingly suggest a controlled, phase-gated approach to software development. Unfortunately, many companies and development organizations interpret FDA regulations to require a steep waterfall. Many industry long-timers incorrectly see agile as an undisciplined style of software development. Neeraj Mainkar demonstrates how those in regulated industries can overcome these and other hurdles. At Neuronetics, he helped implement key elements of agile while fully complying with FDA regulations.
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Neeraj Mainkar, Neuronetics
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Build the "Right Software" to Delight Your Customer Many companies have implemented quality programs such as CMM®, TQM, Six Sigma, etc., to improve requirements and software development. However, these initiatives often focus on building the software right-meeting quality expectations and specifications-but do not necessarily focus on building the right software-the right functionality at the right time and at the right cost from the customer's perspective. Unmesh Gundewar explains how EMC employed the Goal, Question, Metric (GQM) methodology to identify key measurements that ensure the "right software" is being developed. Learn how EMC applies the Six Sigma approach to drive these measurements into the organization and the resulting software. Move beyond the processes designed to get functional requirements and specifications right as Unmesh shares experiences, the challenges faced, and lessons learned from building the right software.
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Unmesh Gundewar, EMC Corporation
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The ROI of Test Automation It is widely known that software inspections are a cost-effective approach for finding defects in source code as well as other project documents such as requirements specifications. You can take your inspection process to the next level by using inspections and the resulting data for process improvement throughout your software organization. Lawrence Day presents a basic process flow for inspecting source code and documentation and the keys to implementing a cost-effective inspection approach. Then, he offers a proven approach for using the inspection data to identify process and product improvement opportunities. By viewing inspections a part of your development process, you'll learn to see inspections as a valuable improvement tool.
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Michael Kelly, Liberty Regional Agency Markets
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Automated Testing for Programmable Logic Control Systems Developing real-time, automated testing for mission-critical programmable logic controller (PLC)-based control systems has been a challenge for many scientists and engineers. Some have elected to use customized software and hardware as a solution, but that can be expensive and time consuming to develop. Reginald Howard shows you a way to integrate a suite of commercially available, off-the-shelf tools and hardware to develop a scalable, Windows-based testing platform that's capable of performing an array of different tests including, but not limited to, black box, destructive, regression, and system security testing. He describes the use of the Jelinski-Morana statistical model for determining expected results from automated tests.
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Reginald Howard, Advanced Systems Integration Inc. and Jon Hawkins, Alliance Technical Solutions
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