ABSTRACT
Computer systems provide an effective method to perform routine and repetitive tasks. Although generally more reliable than manual equivalents, such systems demand adequate controls for equipment setup and programming/configuration. The deliverables that are natural by-products of the SLC are very closely aligned with the "documented evidence" that is required in the Computer Systems Validation (CSV) to ensure a high degree of assurance that the computer system will consistently meet its predetermined specifications and quality attributes. The purpose of CSV is to ensure an acceptable degree of evidence, confidence, intended use, accuracy, consistency, and reliability. A computer system is considered CGMP if the system or any output of the system is used in conjunction with the activities defined in the applicable CGMPs regulation. CGMP computer systems used in production quality systems, whether in the production and process controls, distributing, laboratory testing and analysis, and many other aspects of the quality system associated with manufacturing, must be prospectively validated.
