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Introducing nemedio cTools.
Quality Management System software and compliance tools that fit your engineering process
key features
Document & Change Control →
Design Control & Traceability →
Risk Management→
Training Management →
Project Management→
intuitive and modern documentation
Document & Change Control
21CFR 11 Compliant
Management of Documents, Records & Procedures
Clear Approval Workflows
Practical Peer Review
Guided Change Orders
efficient & convenient management
Design Control & Traceability
Single source of truth for managing Design Inputs
Seamless data management from User needs to Design Transfer to generate DHFs
Individual field configuration for data types
Intuitive and flexible trace matrix
Peer review capability
Compliant & Engineering centered
Risk Management
ISO 14971 Compliant
Mitigation tracking in parallel to device engineering
Current and new risk tracking
automatically managed training records
Learning Management
Document change management
Change Orders
Integration task/project management
Impact assessment assistance to identify records impacted by changes
Compliant & Engineering centered
Project Management
Task Creation and Assignment
Tasks Integrated into Change Orders
CAPA Based Tracking
Want to learn more?
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