Pre-requisite to Effective Validation: Evaluating Your Clinical Trials Software Development Environment Using SEI's Capability Maturity Model for Software

In order to perform effective validation of a computer system you need to incorporate a well-defined software development process into your business model. The development process cannot stand on it own; certain organizational processes and structures must be in place to support the development of validated software. The Software Engineering Institute's Capability Maturity Model for Software offers guidance on incremental steps a software development organization can take to evolve as an entity capable of producing high quality products that meet or exceed the FDA's requirement for the use of validated computer systems in the analysis and reporting of clinical trial results. This paper will focus on the aspects of the Capability Maturity Model for Software leading up to and surrounding the effective implementation and use of a software development life cycle. Practical examples of their use in a clinical trials environment are offered.