White Paper: Automated Testing In FDA-Regulated Environments

By Genilogix, LLC

Modern life sciences companies face many challenges and risks as they push the boundaries of science to invent new medicines and other products in a marketplace that is both highly competitive and stringently regulated. Mandated by the U.S. Food and Drug Administration (FDA), the Computer Systems Validation (CSV) process represents a critical step in the deployment and maintenance of software applications for life sciences companies. To improve the quality, efficacy and safety of products that affect human health, CSV helps verify that the computer systems that manage and maintain electronic records operate in a consistent fashion and yield consistent results based on their intended use.

Business technology optimization (BTO) from HP, together with specific guidance and technology from Genilogix, can help automate and accelerate the validation process across a broad range of applications in use by life sciences companies. Automated testing and validation processes help lower risks through consistent and reliable electronic environments. Through testing and automation technology, validation itself ultimately becomes an effective tool that can contribute to organizational competitiveness, lower costs and risks, and help maintain regulatory compliance.