Computer System Validation It’s More Than （计算机系统验证,这是多）.pdf

Computer System Validation - It’s More Than Just Testing Introduction Computer System Validation is the technical discipline that Life Science companies use to ensure that each Information Technology application fulfills its intended purpose. Stringent quality requirements in FDA regulated industries impose the need for specific controls and procedures throughout the Software Development Life Cycle (SDLC). Evidence that these controls and procedures have been followed and that they have resulted in quality software (software that satisfies its requirements) must be documented correctly and completely. These documents must be capable of standing up to close scrutiny by trained inspectors since the financial penalty for failing an audit can be extremely high. More importantly, a problem in a Life Science software application that affects the production environment could result in serious adverse consequences, including possible loss of life. The activities involved in applying the appropriate controls/procedures throughout the SDLC and for creating the necessary trail of documented evidence are all part of the technical discipline of Computer System Validation. As we will discuss in this article, software testing is a key component in this discipline. However, Computer System Validation, involves more than what many IT people consider to be software testing. What is Computer System Validation and Why is it Important? A key source document providing FDA guidance on the general topic of Validation is “General Principles of Validation, Food and Drug Administration” from the Center for Drug Evaluation and Research. [1]. The definition of Validation in this document is: Establishing documented evidence which provides a high degree of assurance that a