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Quality

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.

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

01

Corrective Action Preventive Action (CAPA)

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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.

02

Audit Management

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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.

03

Document Control

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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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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.

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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.

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