Talk: Overcoming the burden of regulatory evidence using Lean-Agile
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Speaker:
Jane Orme
Talk description
Title:
Overcoming the burden of regulatory evidence using Lean-Agile
Short synopsis:
With the global regulatory environment evolving, even established software might need to face up to the elephant in the room – compliance. Whether you are about to start a project with compliance in mind or need to cover it retroactively, Lean-Agile principles can make it easier to gather the evidence you need to get regulatory approval across a range of sectors.
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Long synopsis (optional):
With the global regulatory environment evolving, even established software might need to face up to the elephant in the room – compliance. Whether you are about to start a project with compliance in mind or need to cover it retroactively, Lean-Agile principles can make it easier to gather the evidence you need to get regulatory approval across a range of sectors. At Bluefruit we have learned from working with medical products with regulatory requirements; however, we feel that the same approach could benefit software design and development in any regulated industry. This talk will cover the Lean-Agile software design and development steps that can be used to implement higher quality software, and how this can be used to generate the required evidence and documentation. Takeaways include: - Essential software development and test plans that are needed for regulatory approval - How software development and compliance documentation can be coupled together - Benefits to developing safety-critical software in an Agile way - Balancing requirements of a Quality Management System with the regulatory requirements for documentation - Using Lean-Agile to interface with non-Agile businesses - Engaging stakeholders with requirement-driven development
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