OOS Software

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.

MasterControl Out-of-Specification™

An OOS doesn’t happen in a vacuum. So, we connect it to all your quality processes.


Corrective Action Preventive Action (CAPA)


Audit Management


Document Control

Trusted By

Factory Lab technician

Correct an OOS During Manufacturing

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.


The Perks of a Platform

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.

Don't leave compliance to chance.

You can't afford to have a disconnected OOS process in a regulated environment. Now's the time to move forward.

Get the Data Sheet
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