By Thomas Wicks, Chief Strategy Officer, TrialScope, Inc.
System validation ensures 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 sponsor’s responsibility to develop a validation program for a system in the context of its operating procedures.
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