Some thoughts on Requirements … using the General Principles of Software Validation to help. Many times we struggle with creating software requirements and documenting them. The FDA General Principles of Software Validation-Final Guidance helps set the FDA expectations in this area. Section 4.1 of the guidance states: “A documented software requirements specification provides a baseline for both...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.