Software Lifecycle activities
We talk a lot in this industry about SLC and the importance of software validation, but how seriously is actual software testing taken. Before a validation document is written or developed in anger, the actual process of how the software was developed should be clearly documented either by the Company/Software house that developed the software of if the software was developed in house. Whether the software was developed in-house of by an external house the deliverables should be the same.
Below is a listing of documented evidence that should be asked for before software is either purchased or validated. It may differ from organization to organization!
• Quality Planning
• System Requirement Definition
• Detailed Software Requirement Specification
• Software Design Specification
• Construction or Coding
• Operation and Support
Several software lifecycle models are defined in the FDA’s glossary of Computerized Systems and Software Development Terminology some of these models include
• Waterfall (most common approach)
• Rapid Prototyping
• Incremental Develpoment