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.

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MasterControl Out-of-Specification™

How Customers Use MasterControl

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.

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

Corrective Action Preventive Action (CAPA)

Worker using out of specification software

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.

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Audit Management

Two coworkers smiling and pointing at a monitor

Effective OOS management is vital to compliance. During an audit, companies have to show the documentation from an OOS. Our audit management system is connected to the rest of the QMS. A user can easily access all the information the auditor needs, when it's needed.

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Document Control

Recording, investigating and resolving an OOS requires documents and approvals. It's a challenge to do that using physical paper. A better option is a document control system that integrates with your OOS and has automated routing, delivery, approvals, escalation and approval.

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