| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 07.05.2014 15:38:22 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | Manage engineering change requests (ECR), 3.2 Absatz 3 (d) |
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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
Research and Development- IP_IP-Management
- RD_Research and Development
- RD_Research and Development
«BusinessProcess» Determine basic product characteristics- «BusinessProcess» Develop Software
- «BusinessProcess» Develop System
- «BusinessProcess» Do SW validation
- «BusinessProcess» Do system / usability verification
- «BusinessProcess» Manage tools and equipment RD
- «BusinessProcess» Plan integration and build functional model
- «BusinessProcess» Plan resources and budget RD
- «BusinessProcess» Provide SERVICE LEVEL 3
- «BusinessProcess» Report RD
- «BusinessProcess» Select and qualify development partner
- «BusinessProcess» Select and qualify development tools
- «BusinessProcess» Start development project
- «BusinessProcess» Manage development process
- «BusinessProcess» Manage engineering change requests (ECRs)
- Manage engineering change requests (ECR)
«Activity» Abandon ECR- «Activity» Create ECR
- «Activity» Generate ECN
- «Activity» Generate ECO
- «Activity» Manage engineering changes
- «Activity» Release engineering change
- «Activity» Review ECR
- «Activity» Update master records
«EndEvent» ECR managed
«StartEvent» PCR or CAPA
«Gateway» Accept?
- «BusinessProcess» Create SysRS / US
- «BusinessProcess» Create DRS
- «BusinessProcess» Create DMRs and MMRs
- «BusinessProcess» Do Design-FMEA
- «BusinessProcess» Do product training
- «BusinessProcess» Do module verification
- «BusinessProcess» Review design phase
- «BusinessProcess» Review design transfer
- «BusinessProcess» Review product release
- «BusinessProcess» Review requirement phase
- «BusinessProcess» Review validation phase
- «BusinessProcess» Review verification phase
- ID_Industrial Design
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox