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QMS Document Management System

A system for managing, controlling, and accessing documents efficiently, ensuring compliance with ISO and FDA standards.

Solution by Qualcy
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Overview

The QMS Document Management System is designed to streamline the management and control of documents within an organization, ensuring that only current documents are accessible to users. It facilitates efficient document approval processes by respective reviewers and enhances user access and search capabilities.

This system complies with ISO standards, FDA Regulations (21CFR part 820 for medical devices), and AS standards, making it suitable for organizations that need to adhere to these regulations. It is user-friendly, easy to implement, and configure, with built-in error-proof mechanisms to prevent errors during use.

Key Features and Capabilities

  • Role-based identification and secure login access control.
  • Workflow inbox capabilities for centralized visibility of notifications, tasks, and projects.
  • Customizable number of approvers for each project, with options for department-specific approvers.
  • E-signature capability that is auditable and traceable.
  • PDF printing with timestamps and individual traceability.
  • Support for attaching various file types, including audio and video.
  • Drag-and-read text boxes for easy content viewing.
  • Automated reminders for task and project owners and approvers.
  • Options for creating and exporting metrics and reports to Excel for management review.
  • Configurable labels for text boxes to suit user preferences.

The system is designed to handle the vast number of documents and records organizations deal with daily, overcoming the challenges of manual, paper-based systems. It supports scalable processes for both small enterprises and large organizations, ensuring consistent compliance with customer requirements and regulatory standards.

Meta

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