D Addressing 21 CFR Part 11 Requirements with an Automated Configuration Audit

by David Deitz This article describes how configuration software changes are commonly tracked and managed today using “paperbased” configuration audit trails, the shortcomings of the paper-based solutions, and a new automated computer-based configuration audit trail that addresses the shortcomings of the traditional paper-based solutions. Introduction esigning and implementing process control software is an interactive and ongoing process. There are several reasons for this. In some instances, specifications for the process control software lack the necessary detail to accurately design and implement the required control in a single attempt. In others, the process equipment that the process control software must interact with lacks features or functionality that it was assumed to support at the time the process control software was designed. Even in a ‘perfect’ situation in which the process control software was implemented exactly as specified and no process equipment issues needed to be addressed, configuration software changes would undoubtedly be required as the process is optimized to maximize product quality and throughput. When process control software is designed and implemented within a facility that is regulated by the FDA, procedures must be put in place to ensure that the software can be validated to perform as expected. In this case, the need for change control policies and procedures has been documented in numerous guidelines and papers on computer systems validation. In addition, the computer systems validation lifecycle models developed by the PDA and GAMP both identify the importance of ongoing change monitoring and change management.