Preliminary Incident Impact Analysis
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This section provides a structured summary of all identified incident impacts, with details such as description, type, and severity level. The Overview includes:
Impact Description: Details the nature and consequences of the identified impact.
Type of Impact: Categorizes the impact (e.g., Safety, Regulatory, Production).
Severity Level: Indicates the level of risk associated with the impact (e.g., Critical, High, Medium).
Erasing Impacts: Click the erase icon to remove an impact entry.
Notes: Deleted root causes cannot be restored.
The Impact Registration section allows you to define and document key details about an incident's impact. This ensures a structured evaluation of its consequences and severity, supporting risk assessment and corrective actions. Fields marked with an asterisk (*) are mandatory for record creation and proper functionality.
The audit trail maintains a chronological, uneditable log of all recorded impacts, 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.
To document an additional impact, click the in the top-right corner. You can modify the description, type, and severity level directly from the table.
