| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 03.05.2014 11:51:31 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 2. CE declaration of conformity, 7.5.9.1 Allgemeines, 7.5.8 Identifizierung, 7.5.3.1 Identification, 7.5.3.2.1 General, CFR 820.184 Device history record, 7.5.1 Lenkung der Produktion und der Dienstleistungserbringung, Build device, CFR 820.60 Identification, CFR 820.65 Traceability, 7.5.1.1 General requirements, CFR 820.120 Device labeling |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
- Clinical Marketing
- Research and Development
- Operations
Operations- IE_Industrial Engineering
- LG_Logistics
- PD_Production
- PD_Production
«Activity» Build device- Build device
- «Activity» Create DHR
- «Activity» Document device complete
- «Activity» Document device manufacturing
- «Activity» File modules build into device
- «Activity» Label device and affix CE mark
- «Activity» Manufacture device
- «Activity» Prepare device manufacturing
- «Activity» Receive production order and type plate for device
- «Activity» Store device
- «Activity» Take production modules from stock
- «Activity» Take production parts from stock
«EndEvent» Device built
«StartEvent» Need for new devices
«Gateway» Device blocked?
- «Activity» Build module
- «Activity» Build sterile modules
- «Activity» Do module acceptance test
- «Activity» Inspect new parts
- «Activity» Manage nonconformities of parts
- «Activity» Manage nonconformities of production process
- «Activity» Manage production
- SCM_Supply chain management
«BusinessProcess» Plan resources and budget Operations- «BusinessProcess» Report Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox