Compliance and Agile In a prior blog, we discussed a common hurdle to achieving agile benefits: focusing on isolated software process changes and not considering all four organizational factors. Another common hurdle to agile success is thinking only about making agile “compliant.” You will miss the full power of agile if you do not consider...Read More

The link provided is to a white paper prepared by Northwest Cadence regarding use of Microsoft Visual Studio to aid in compliance with FDA requirements. Food and Drug Administration (FDA) Compliance with Visual Studio 2010Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached zip file contains 3 training templates. One is for an example software development SOP, one is a companion software development plan, and one is a template for software risk analysis incorporating the concept of predefined categories of...Read More