| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 14.03.2014 10:24:04 |
| Modified: | 03.09.2019 15:54:53 |
| Advanced : | |
| Appears In: | 7.1 Planung der Produktrealisierung, RD_Research and Development, Start development project, Manage and create PCRs, 7.1 Planning of product realization, 3.2 Absatz 2, 7.3.1 Design and development planning, CFR 820.30 Design controls, 7.3.3 Design and development outputs |
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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
- Manage development project
«Activity» Create / update glossary- «Activity» Create / update project plan
- «Activity» Create / update quality and risk management plan
- «Activity» Manage DHF
- «Activity» Manage DMR
- «Activity» Manage ETF
- «Activity» Manage MMR
- «Activity» Manage project issues
- «Activity» Setup and maintain project folder structure in version control system
- «Activity» Setup document-ID list
«EndEvent» Development project managed
«StartEvent» Need to manage development project
- «BusinessProcess» Manage engineering change requests (ECRs)
- «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