Adapting Agile Methodologies for Use in Regulated Industries Such as Aerospace & Life Sciences
How to adapt agile techniques for planning, development and testing so that they can be used in larger more complex situations that have a high degree of regulatory complexity, such as life sciences, aerospace, automotive and defense. In this session I would like to discuss my experiences with planning, developing and testing software applications in industries such as healthcare and finance that are heavily regulated by the Government, with strict requirements for validation, traceability and evidence. During the session, I will provide several actual examples, based on experiences and real-world war stories from our clients in these industries. We will cover the role of requirements gathering and user story development, sprint planning, testing and continuous development, and how they can be applied in this unique and challenging environment. The session will include specific tips around FDA testing, HIPAA and GDPR data privacy, as well as how to comply with the testing and validation requirements of projects in specific industries. We shall also cover the rules, regulations, and reporting requirements, and present ways to harness agile approaches, and yet be able to provide the information needed by regulators and other audit agencies to ensure the products being tested are compliant.