Author: Brian Shoemaker, Shoebar Associates
Source: 1st Annual Medical Devices Conference (Nov 2012, San Francisco)
Every company, every software development team works somewhat differently. Each distinct product category involves its own set of development tasks. A “one size fits all” approach to software quality procedures therefore is not useful; software SOPs instead need to be tailored to the team and tasks while fulfilling regulatory expectations.
The questions and suggestions below were developed to help teams generate their own software SOPs. They outline many key topics in a typical set of software procedures (“XYZ” is your company’s name)