| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 22.05.2014 20:04:58 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 7.5.9.1 Allgemeines, 7.5.8 Identifizierung, 7.5.3.1 Identification, 7.5.3.2.1 General, Build sterile modules, CFR 820.184 Device history record, CFR 820.60 Identification, CFR 820.65 Traceability, 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- «Activity» Build module
- «Activity» Build sterile modules
- Build sterile modules
- «Activity» Assembling of to be sterilized module (if applicable)
- «Activity» Boxing of sterilized modules
- «Activity» Clean parts according to validated cleaning process
- «Activity» Create sterilization report
- «Activity» Inform NB about release of a new batch including respective certificates
- «Activity» Label lot number
- «Activity» Label sterile product
- «Activity» Pack module to be sterilized
- «Activity» Pack sterilized modules into outer packaging
- «Activity» Sterilize module
- «Activity» Store sterilized modules
- «Activity» Take non-sterile parts from stock
«EndEvent» Module sterilized
«StartEvent» Need to sterilize product
«Gateway» Product containing human blood derivates?
- «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