Actions
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This section is divided into two parts:
Preliminary Actions: Displays containment actions from the Investigation Request in read-only mode. These actions cannot be modified.
Actions: Provides a structured summary of all actions within the investigation, including containment, corrective, preventive, follow-up, and effectiveness actions.
Overview Includes:
Name: Displays the action name, action ID number, and the assigned user.
Action Due Date: Indicates the deadline for completing the action. The system provides a visual countdown to track the remaining days until the due date:
Red: The due date has passed or is due today.
Orange: The due date is within the next 30 days but more than 5 days away.
Green: The due date is more than 30 days away.
If the action is marked as Done or Canceled, only the due date will be displayed, without the countdown.
Reviewers: Indicates whether the action has assigned reviewers and the total number of reviewers. Once all reviewers have completed their signatures, the icon will change from gray to green.
This section allows users to define and document actions. These ensure a structured approach to tracking and completing corrective and preventive measures. Fields marked with an asterisk (*) are mandatory for record creation and system functionality.
Action Due Date: Specifies the deadline for completing the action.
Completed At: This field is automatically populated when the action status changes to Done and cannot be manually modified.
Related Actions: Allows linking other actions within the investigation that may be dependent or associated with this one.
Notes: Deleted actions cannot be restored.
To add a related action, its status must be Pending or In Process.
To remove a related action, click the (X) icon in the Related Actions field.
The Related Actions field allows the selection of multiple actions if applicable.
After creating the action, the Attachments section becomes available, allowing users to upload and manage related files. Files can be added by dragging and dropping them into the upload area or clicking the Upload files option. The system supports files up to 5 MB in size.
Once uploaded, attachments are listed with their file name, format, and upload timestamp. Uploaded attachments contribute to the available storage space and count toward overall usage.
Notes: Deleted attachments cannot be restored.
Facilitates communication by allowing users to exchange messages and share updates related to the action.
Enables the management of reviewer responsible for verifying the action.
The audit trail maintains a chronological, uneditable log of all recorded actions, ensuring data integrity, compliance, and traceability. Click the audit trail icon to view event details, including performed actions, timestamps, and responsible users.
Pressing the print icon allows users to print or download the audit trail report.
When printed, the report will include a stamp with a unique control number, the name of the user who initiated the print, and a timestamp detailing the date and time it was generated. This information is located in the document footer, as shown in the example below. The design complies with cGMPs, ALCOA, ALCOA+, and other data integrity and security standards for forms and documents.
Notes: Audit Trail log is intended to comply with the cGMP audit trail requirements of the 21 CFR Part 11.
Status: Shows the current of the action (Pending, In Process, Done, or Canceled).
View Details: Click the to access detailed information about the action.
Actions can be reordered by clicking and dragging the reorder icon to adjust their position. To document a new action, click the in the top-right corner. The due date and status can be modified directly from the table.
