System validation refers to a company’s approach to ensuring that a system (a combination of hardware, software, users, training and processes) meets its intended use and provides a consistent, predictable output. Documentation throughout the Software Development Life Cycle (SDLC) is required from software vendors to illustrate that procedures are followed and controls are implemented to produce quality software. It is the life sciences organization’s (sponsor) responsibility to develop a validation program for a system in the context of their operating procedures.
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