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Out of Specification (OSS) Software
Out of Specification (OSS) is one of several quality processes that is included in the Quality Manager module. Moving to an electronic system automates the routing, notification, escalation, and approval for your OSS records. It also provides a centralized repository for all OSS related documentation that makes search and retrieval easy.
Quality Manager’s configurable forms tool allows for the easy creation of a form to meet each company’s specific needs. Some of the fields available include identity of major equipment/lines used, components/materials affected, identification of personnel supervising or checking each step, with a complete coding system to assess the risk.
The task manager automates task assignment and follow-up via automatic e-mail notification. Any recurring OSS-related activities can be included in a task profile, however users have the option to add tasks on an ad-hoc basis to individual OSS events. Quality Manager incorporates escalation capability for any task not completed by deadline.
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Title21 Software’s Out of Specification:
• Meets 21 CFR Part 11 requirements with a signature manifestation that includes name, date, time, and meaning of electronic signature (reviewed, approved, rejected, etc.)
• Decreases time spent tracking down pieces of information; a central repository allows for easy search and retrieval
• Allows companies to become virtually paperless
• Is part of the Quality Manager Module, so other quality events such as Equipment Calibration, Batch Records, CAPAs are linked to ensure compliance with FDA regulations and ISO quality standards
• Integrates with the Document Control and Training Modules to create a “Closed Loop” Quality Management Solution
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Some of the reports available include:
OSS History: Shows the OSS event as “in process” or “complete” along with all electronic signatures.
OSS Detail: Details equipment used, production lines affected within specific date ranges.
OSS by Owner: Lists OSS categorized by owner within specific date ranges.
Open OSS: Lists open OSS categorized by department and owner.
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