Incident Record Security Design
The Incident Record Security Design Specification introduces a robust and flexible access control model to support the upcoming Records module within the Quality Management System (QMS). This design ensures that sensitive quality records, such as Incidents, Investigations, and CAPAs, are securely managed throughout their lifecycle, with permissions dynamically adjusted based on user roles, team assignments, and workflow progression.
At its core, this feature enforces record-level security, ensuring each incident record has individualized access rules. Users gain visibility and edit rights based on their roles (e.g., Admins, Process Owners), direct assignments (e.g., Investigators, Workflow Participants), or actions taken within the system. Room-level settings allow Super Admins to activate the Records module and configure access at a granular level, while supporting the separation of privileges between the Records and Documents modules.
Upon creation, incident records automatically grant access to key stakeholders, including the Originator, Process Owner, and Room Admins. As the incident progresses through the workflow, permissions are adapted in real-time, ensuring originators transition to a read-only role, while team members and stage-specific contributors gain access aligned with their responsibilities. Special provisions allow external Investigators to participate without compromising broader system visibility.
Additionally, clear rules govern record deletion and obsolescence, balancing administrative control with data integrity. Draft records can be deleted by Originators and Admins, while workflow-submitted records can only be marked obsolete by authorized users.
This security design supports scalable, audit-ready governance of quality records, enabling organizations to maintain strict data confidentiality, ensure proper accountability, and streamline compliance. By embedding permission logic into the incident lifecycle, this feature fosters a secure, transparent, and collaborative environment for managing quality events.
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