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QMS NC Management

A comprehensive solution for managing process and product non-conformances with features like role-based access, workflow inbox, and customizable reporting.

Solution by Qualcy
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Overview

The QMS NC Management system offers a comprehensive solution for handling process and product non-conformances. It facilitates the creation of NC records and ensures effective communication with NC owners and approvers. The system is designed with role-based identification, secure login, and access control, making it both secure and user-friendly.

Key features include workflow inbox capabilities that provide visibility of notifications, tasks, and projects, ensuring users only see relevant tasks and notifications. The system allows for flexible assignment of approvers, with options to specify the number and departments of approvers for each project.

Features and Capabilities

  • Role-based identification and secure login.
  • Workflow inbox for task and notification management.
  • Customizable approver assignments.
  • E-signature capability that is auditable and traceable.
  • PDF printing with timestamps and traceability.
  • Support for attaching various file types, including audio and video.
  • Drag-and-read text boxes for ease of use.
  • Automated reminders for task and project owners.
  • Options for creating metrics and exporting data to Excel for customized reports.
  • Configurable labels for text boxes.

The system is designed to handle and document non-conformance scenarios effectively, aiming to identify root causes and implement corrective actions to prevent recurrence. It is customizable to meet specific process requirements and ensures compliance with industry standards such as ISO, 21CFR part 820 for medical devices, and AS standards.

For more information or to request a demo and a 30-day free trial, please contact us.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & Compliance
Target user(s)
QA / Regulatory Affairs
Tag(s)
Quality & Compliance Management