| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 27.02.2014 19:16:56 |
| Modified: | 03.09.2019 15:16:55 |
| Advanced : | |
| Appears In: | 7.1 Planung der Produktrealisierung, RD_Research and Development, 5.2 Customer focus, 7.2.1 Ermittlung der Anforderungen bezüglich des Produkts, 7.3.3 Entwicklungseingaben, 7.1 Planning of product realization, 7.2.1 Determination of requirements related to the product, 7.3.2 Design and development inputs, 3.2 Absatz 3 (c), CFR 820.30 Design controls, PM_Product Management, 5.2 Kundenorientierung |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
- Clinical Marketing
Clinical Marketing- CA_Clinical Affairs
- CAM_Clinical Application Management
- MC_Marketing & Communications
- PM_Product Management
- PM_Product Management
«BusinessProcess...» Aquire reference site
«BusinessProcess» Create PRS- Create PRS
«Activity» Consider customer input- «Activity» Consider experiences derived from previous developments
- «Activity» Create PRS
- «Activity» Create traceability between validation and PRS
- «Activity» Create validation plan
- «Activity» Model House of Quality if applicable
- «Activity» Pre-Assess (unmet) customer user needs and market information
- «Activity» Translate customer needs into product requirements
«StartEvent» Intended product development
«EndEvent» PRS specified
- «BusinessProcess» Create USI
- «BusinessProcess» Define USPs
- «BusinessProcess» Do product validation
- «BusinessProcess» Gather product specific market and clinical information
- «BusinessProcess» Manage and create PCRs
- «BusinessProcess» Manage internal / competition market survey
- «BusinessProcess» Plan product roadmap
- «BusinessProcess» Propose product positioning
- «BusinessProcess» Survey competitor business strategies
- «BusinessProcess» Survey market development
- TW_Technical Writing
«BusinessProcess» Manage compentencies CM - «BusinessProcess» Manage tools and equipment CM
- «BusinessProcess» Plan resources and budget CM
- «BusinessProcess» Report CM
- Research and Development
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox