Where’s the Fine Line Between the Product Team and the Engineering Team?
In the rush to build a product, it’s important to establish boundaries for each team while also working as a unit, and develop processes to head off trouble before it begins.
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Prepping for an FDA Inspection Part 2: Logistics
FDA Inspection Intro In Part One of this two-blog series, I shared 5 best practices to prepare your organization for FDA inspection success. Inspections by the FDA can lead to regulatory action and consequences such as warning letters, recalls, and consent decrees. Thus, you want to put your best foot forward to demonstrate the compliance […]
Requirements Traceability: Links in the Requirements Chain, Part 1
Derived requirements traceability is a form of requirements management focused on tracing requirements that aren’t explicitly defined in higher-level requirements, but which are necessary for meeting them and for making the overall system work as expected.
What is Requirements Traceability and Why Does it Matter for Product Teams?
Learn why requirements traceability – the ability to trace requirements – for complex products is crucial for product teams.
What is Traceability?
Learn why requirements traceability – the ability to trace requirements – for complex products is crucial for product teams.