Smart Facility Automation Solutions To Ensure Regulatory Compliance

This paper demonstrates how an integrated facility automation system helps life science industries attain and maintain regulatory compliance—specifically, Food and Drug Administration (FDA) regulation s dictating electronic records. The concept of Total Environment Management is introduced, whereby a holistic view of the entire facility provides the framework not only for regulatory compliance but optimized operations. Appropriate use of electronic records and signatures is examined, as well as the practicalities of ensuring compliance through thorough system validation.