| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 20.12.2013 09:21:44 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | CFR 820.140 Handling, 8.2.6 Überwachung und Messung des Produkts, CFR 820.184 Device history record, 7.5.1 Lenkung der Produktion und der Dienstleistungserbringung, Build module, 8.1 General, 8.2.4.1 General requirments, Repair blocked parts in-house, 8.1 Allgemeines, PD_Production, 7.5.1.1 General requirements, CFR 820.70 Production and process controls., Refurbish modules, CFR 820.80 Receiving, in-process, and finished device acceptance. |
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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- «Activity» Build module
- «Activity» Build sterile modules
- «Activity» Do module acceptance test
- Do module acceptance test
- «Activity» Check valid calibration of test tool and do reference measurement before first use
- «Activity» Execute module acceptance test
- «Activity» Input statistic data
- «Activity» Label module as approved
- «Activity» Prepare module acceptance test
- «Activity» Return test tool after use
«EndEvent» Module acceptance test executed
«StartEvent» Module ready for acceptance test
«Gateway» Final acceptance test ok?
- «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