Out of Specification (OOS)

The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

Interconnected OOS software lets you comply with U.S. Food and Drug Administration (FDA) regulations and ISO standards. Current good manufacturing practices (CGMPs) require regulated manufacturers to follow specifications that define parameters for a product. When a product is OOS, a company must investigate and document the results.