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“Regulations are designed with safety in mind. They are not really designed for DevOps” Jaimie and Heidur sharing insights from bringing devops to the pharma supply chain during Operation Warpspeed. :star-struck:🚀

The FDA guidance Jaimie described: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation

Great description from @jaimie of The Compliance Downwards Spiral 🌀 Non-compliant actions need to be addressed to prevent them happening again, which leads to more complex procedures, which increases the risk of non-compliant actions.

@mirco.hering’s description of autonomy not being giving engineers completely free choice over tools and processes, but providing the guidance and tools they need to be successful in achieving their outcomes themselves.

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One of the most overlooked challenges in Continuous Compliance / Automated Governance is documenting requirements. Getting stakeholders to codify their expectations can be like pulling teeth, but it’s a great opportunity to bring Security, Risk, and QA into the fold and bridge the gap between silos.

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