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Origami OOS Management

Carry out Out- of- Specification Lab Investigations in a specified way

Origami Out of Specification (OOS) management software ensures that out of specification lab investigations are undertaken, the root causes are identified, conclusions are reached and properly followed upon. It is inevitable for all pharmaceutical and combination- product manufacturers and is guided by cGMP and 21 CFR parts 210 and 211.

The Origami OOS management software encompasses a number of features that include:
The FDA prescribes a two-step approach to ensure compliance with lab results. The Standard Operating Procedures (SOPs) and other specification documents are integrated to the software system that also hosts supervisor checklists to ensure that out of specification lab findings are stored on the centralized system and eases out an FDA audit.
Consistent investigation
Quick solutions
Origami OOP management software keeps everyone connected. Team members are immediately notified through emails and personalized dashboards about the root causes and results of the investigation. The subject matter experts can quickly respond to when needed, strengthened by the milestone dates and escalation features.
The Origami OOP management software comes with intelligent reporting tools that let you know about impending issues regarding lab equipment, procedure, or personnel. This in turn helps you to make changes in your system or workflow to ensure optimal quality. It lets you know whether a lab procedure needs to be updated or a technician needs to rectify his current mode of operation and so on.
Reporting tools to improvise your system
Integrate and escalate when needed
CAPA may not be required for all lab investigations. But when the need arises, Origami’s OOP management software steps up in the game by either generating a new CAPA or integrating an existing CAPA document through the RPN (Risk Priority Number).

Developed on the Origami Platform for Compliance, our OOP management software is capable of tailoring, extending, and integrating processes with the growing demands of the organization. This is achieved through Origami’s configuration tools, platform services, and enterprise integration services. Also, Origami’s cloud-based deployment options and automated validation tools help to add new processes and get working on them on the go!

Extend and integrate quality processes
OOP management software is integrated into Origami quality management software.

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