Quality Events
A screenshot of the Inventory Management module.

The Quality Events module is designed to provide a streamlined, comprehensive tool for managing quality events within the GMP manufacturing process. It includes the following key features:

  1. Event Logging: Capture all significant events across the manufacturing process, such as deviations, non-conformances, and complaints.
  2. Automatic Alert System: Provides automatic notifications when a quality event occurs, ensuring quick reaction and response.
  3. Risk Assessment Integration: Seamlessly integrates risk assessment at every stage of the event management process to prioritize action based on risk level.
  4. Root Cause Analysis: Offers an effective way to conduct root cause analysis.
  5. Corrective and Preventive Action (CAPA) Management: Allows for effective planning, execution, and tracking of corrective and preventive actions to mitigate risks and prevent recurrence of issues.
  6. Audit Trail: Maintains a chronological record of all activities related to a quality event, assisting in both internal and external audits.
  7. Real-time Reporting: Interactive dashboards and detailed reports that provide an at-a-glance overview of the quality event status.
  8. Integration with other modules: Works seamlessly with other Bluecord modules, such as document control, training, and CAPA.
  9. Regulatory Compliance: Built with regulatory requirements in mind, it assists in maintaining compliance with GMP standards like FDA 21 CFR Part 11, SOC 2 Type 2, and HIPAA.
  10. User-friendly Interface: Designed with a clean, intuitive interface, making it easy for all team members to use and understand.
  11. Secure Data Management: Ensures high-level data security and privacy, incorporating encryption, secure access controls, and redundancy to protect your sensitive information.
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