Making Agile Work in Highly Regulated Environments
Highly regulated industries—avionics suppliers, medical device companies, and pharmaceutical manufacturers—must meet rigorous quality standards to ensure their products are not a danger to the general public. Although compliance has traditionally been achieved with heavyweight waterfall or V-model development methodologies, you can implement agile—or lean-agile—development practices that adhere to standards-based regulations while reducing the risk and improving software quality and reliability. Colin Doyle identifies the constraints that agile and lean-agile software development approaches must address: traceability to clearly defined requirements, formal risk analysis and mitigation, and separation of roles between development and validation. Colin describes ways to leverage agile practices within regulatory constraints, offering specific examples from the commercial avionics standard DO-178B and FDA CDRH software validation guidelines. Take back specific recommendations for implementing agile and lean-agile practices that work within formal standards and demonstrate to regulatory agencies or auditors that appropriate processes are defined and followed.
Colin Doyle has more than twenty-five years of experience in systems engineering and software development in fields as diverse as avionics, satellite communications, medical devices, precision laser systems, and enterprise content management. He has worked on both plan-driven and agile projects, ranging from classic waterfall following the DOD-STD-2167A and DO-178B standards to Scrum and Extreme Programming. Colin is a customer requirements manager at MKS, where he manages the development of the MKS Integrity platform for application lifecycle management, focusing on processes and practices. As part of that role, he is actively involved with agile user groups in both Kitchener-Waterloo and Toronto.
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