VERIFYING COMPUTER BASED SYSTEMS INTEGRAL TO DEMONSTRATING COMPLIANCE

摘要

As processes, regulations, and operations become significantly more complex, staffing and personnel are stretched ever thinner, process and compliance data are integrated with enterprise management systems, and the use of computers for tracking and reporting compliance data increases, how do you know that your computer systems are keeping you compliant? Computer based systems are integral with process control for air pollution control systems. They play significant roles in continuous emissions monitoring systems and data acquisition systems. The use of word processing, spreadsheet, and data base programs for filing reports is ubiquitous. Regardless whether your quality system is ISO, Six Sigma, the FDA qualification process or corporate, there are common elements, methodology, and procedures for verifying that the system meets requirements. Building on a paper presented in 2002 by Schomer and Wintersteen which described the preparation of a functional specification to define requirements for a control system to achieve compliance with HWC MACT, this paper will provide an overview of a quality system approach to verify that your computer system does what it is supposed to do. The overview will include real world examples to illustrate the practicality of the approach.