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CAPA System

A comprehensive solution for managing corrective and preventative actions (CAPA) processes, ensuring compliance with standards like ISO9000 and 21CFR part 820.

Solution by Qualcy
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Overview

The CAPA System offers a complete solution for managing corrective and preventative actions, essential for continual improvement and compliance with standards such as ISO9000, 21CFR part 820 for medical devices, and AS9000. This system is designed to be intuitive and easy to implement, applicable to both transactional and non-transactional processes, including planning, marketing, customer service, and manufacturing operations.

Built on the latest technology platforms, the CAPA System provides features that enhance usability and efficiency. It includes error-proof mechanisms to prevent mistakes during use, and role-based identification with secure login and access control, ensuring tasks and projects are not delayed by personnel availability.

Key Features

  • User-friendly interface that is easy to configure and implement.
  • Workflow inbox capabilities for centralized visibility of notifications, tasks, and projects.
  • Customizable number of reviewers and approvers per project, with departmental specifications.
  • E-signature capability for auditability and traceability.
  • Pdf printing with timestamps and individual traceability.
  • Support for attaching various file types, including audio and video.
  • Drag-and-read text boxes for enhanced readability.
  • Automated reminders for task and project owners, and approvers.
  • Options for creating metrics and reports, with data export to Excel for customized reporting.
  • Configurable labels for text boxes to suit user preferences.

The system is designed to be auditable and traceable, supporting the creation of comprehensive records and reports. It provides a robust framework for organizations to ensure compliance and drive continual improvement.

Meta

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