| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 08.04.2014 17:05:07 |
| Modified: | 27.02.2018 10:15:33 |
| Diagram Elements : |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management
Management- Management
- AD_Administration
- GM_General Management
- GM_General Management
«BusinessProcess» Do business planning and budgeting- «BusinessProcess» Manage contracts
- «BusinessProcess» Nominate of legally demanded roles
- «BusinessProcess» Create terms of business
- «BusinessProcess» Define and communicate company mindset
- «BusinessProcess» Do management review
- Do management review
«Activity» Create management review report- «Activity» Create new internal complaints derived from management review
- «Activity» Review medical device reportings
- «Activity» Review and consider influences onto QMS
- «Activity» Review and update quality goals
- «Activity» Review and update quality policy
- «Activity» Review customer feedback
- «Activity» Review executed CAPAs
- «Activity» Review new legal requirements
- «Activity» Review previous management reports
- «Activity» Review process performance
- «Activity» Review product roadmap
- «Activity» Review quality audit report
- «Activity» Review reports provided by functional units
- «Activity» Review service statistics
- «Activity» Review summary of last regular audit
«StartEvent» Annual managment review
«EndEvent» Management review complete
- «BusinessProcess» Plan and provide resources
- «BusinessProcess» Regulate responsibilities and communication
- «BusinessProcess» Assign signature approval authorities
- Quality and Regulatory
- Clinical Marketing
- Research and Development
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox