QMS (Quality Management System)
The QMS section in RapidFacto provides a comprehensive set of tools for managing your organization's quality management system. It covers document control, approval workflows, training, internal audits, corrective and preventive actions (CAPA), complaint handling, and management review meetings (MRM).
Modules
| Module | Description |
|---|---|
| Roles | Create and manage approval roles that group users for approval workflows |
| Approval Workflows | Define multi-step approval processes for documents, audits, CAPAs, and more |
| Training | Create training modules, assign them to roles, and track completion with quizzes |
| Internal Audit | Plan, execute, and track internal audits with checklist templates and findings |
| CAPA | Manage Corrective and Preventive Actions from root cause analysis to closure |
| Complaints | Log, investigate, and resolve customer and internal complaints |
| MRM | Schedule, conduct, and document Management Review Meetings |
How It All Connects
The QMS modules are deeply interconnected:
- Roles are used by Approval Workflows to determine who can approve or reject items.
- Approval Workflows are used across Internal Audits, CAPAs, Complaints, and MRM to enforce structured approval before closure.
- Internal Audit findings can be directly linked to CAPAs for follow-up corrective actions.
- Complaints can be linked to CAPAs when corrective/preventive actions are required.
- Training modules can be assigned to users in specific Roles, ensuring that personnel in approval or audit roles stay trained.
- MRM meetings review the status of audits, CAPAs, complaints, training, and overall quality system performance.
Permissions
Access to QMS modules is controlled through claims. The following claims govern access:
| Claim Prefix | Modules |
|---|---|
DOCUMENT | Documents, Records |
APPROVAL | Roles, Approval Workflows, Pending Approvals |
TRAINING | Training |
AUDIT | Internal Audit |
CAPA | CAPA |
COMPLAINT | Complaints |
MRM | MRM |
LOGBOOK | Logbooks |
Each claim supports granular levels: ALL_ACCESS, READ, WRITE, UPDATE. Users with ADMIN:ALL_ACCESS have full access to all QMS modules.