How CASE Management Works in MedQdoc #
CASE Management in MedQdoc provides a structured and traceable way to manage quality-related processes within the QMS.
Overview of CASE Management #
In MedQdoc, CASE Management is used to control and document quality-related processes using predefined templates and structured workflows. Each CASE follows a series of defined steps from initiation to completion, ensuring consistency, accountability, and regulatory compliance.
- Standardized process templates for consistent case handling
- Step-by-step workflows with clearly defined actions
- Automated status transitions based on completed steps
- Integrated review and approval aligned with 21 CFR Part 11 and ISO 13485
- Audit-ready traceability with full activity logging
- Customizable templates to support your own case types and workflows
CASE Structure in MedQdoc #
Standardized Framework #
Each CASE in MedQdoc is built on a standardized template that defines its structure, content, and workflow. Every template includes multiple CASE steps—typically five or more—that guide users through the process from initiation to completion. This framework ensures all quality processes are handled in a controlled and compliant manner.
Purpose-Driven Steps #
Each CASE step has a clear and specific purpose, such as information gathering, risk assessment, or action tracking. By following these structured steps, users maintain full traceability and regulatory compliance throughout the case lifecycle. This standardized approach ensures consistent documentation across different case types, making audits and reviews efficient and reliable.
Result: Every step in MedQdoc CASE management is fully documented, traceable, and audit-ready, supporting continuous compliance and operational transparency.
The CASE module supports all key quality management processes required by MedTech companies and can be linked directly to QMS records and technical documentation.
This ensures full traceability and compliance with ISO 13485, EU MDR (2017/745), and FDA QSR (21 CFR Part 820). Stay audit-ready, compliant, and confident — all within MedQdoc.
Additional Resources #
Internal references
Downloads
