Out Of Specification (OOS) Software For Life Sciences


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.

Customers worldwide use MasterControl to automate core business processes. The out-of-specification product works with the rest of the QMS to expedite compliance and speed time to market.

Sometimes an OOS is a sign of a bigger problem. If a corrective action preventive action (CAPA) is required, a CAPA form can be started directly from the OOS product. This reduces human error and ensures continuity.

Part of the tension between quality and manufacturing comes from quality events, such as OOS. In-line quality event management eases this tension. With a solution like MasterControl Manufacturing Excellence, an out of specification during the manufacturing process can be fixed without slowing down the process.

Quality and manufacturing are only two parts of the product life cycle. There's also product development, clinical, regulatory, supplier, and postmarket. A platform approach interconnects all processes and stores data and documentation on the same cloud-based system.