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© 2023 CIQA QMS by Computer Integration of Quality Assurance

On this page
  • Investigation Record
  • Creation & Storage
  • Incident for Investigation
  • Process Hold Evaluation: Diagnosis Assessment
  • Disposition

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  1. Help Center
  2. CIQA eQMS User Guide
  3. Modules
  4. Quality Assurance Management
  5. Incidents, CAPA & NC Management
  6. Investigations Management

General Information

PreviousInvestigation OverviewNextRecord Status

Last updated 3 months ago

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Investigation Record

To initiate an investigation, an incident must first be registered, followed by the creation of an Investigation Request. Investigations are automatically generated when a request is approved with the decision "Need a New Investigation."

This section outlines the essential details of an investigation, including:

  • Investigation Name and ID Number: Pre-filled with details from the associated request but can be modified if necessary.

  • Status: Indicates the current status of the investigation (Open, Under Review, Approved, Closed, or Canceled).

  • Investigation Request Number: Assigned by the system based on the request that triggered the investigation. This field is locked for edits. To access more details, users can click the external link icon to open the related request.

  • Description: Populated using the Conclusion field from the Investigation Request but remains editable if additional context or modifications are required.

Creation & Storage

This section also includes storage-related details and record management functionalities:

  • Created By: Automatically set to the user who approved the investigation request.

  • Created Date: Captures the timestamp of when the investigation is generated and remains uneditable.

  • Owner and Department: Initially inherited from the investigation request but can be updated.

Some fields, such as Created By and Created Date, are system-generated to ensure traceability, recording both the initiating user and the exact timestamp of creation.

Incident for Investigation

This section displays details of the incident under investigation, sourced directly from the Investigation Request. Clicking on it will expand the view, providing complete incident information. This allows for easy access and helps maintain a clear sequence of events throughout the investigation.

Process Hold Evaluation: Diagnosis Assessment

Evaluates whether production, manufacturing lines, equipment, or related processes should be temporarily halted due to the ongoing investigation.

Disposition

Determines if the investigation has been successfully completed based on its findings and conclusions.

To understand the icons in the top-right corner, click . Some icons, such as delete, remain inactive to maintain data integrity.

By default, the investigation is assigned to the user who initiated it, referred to as the Owner. Ownership can be reassigned if needed. If the value you want to add doesn’t appear in the list, click the to navigate to the related form.

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