| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 23.04.2014 16:53:16 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | Manage CAPA process, 8.5.2 Korrekturmaßnahmen, 8.5.2 Corrective action, 8.5.3 Preventive action, 8.5.3 Vorbeugungsmaßnahmen |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
Quality and Regulatory- QA_Quality Assurance
- QA_Quality Assurance
«BusinessProcess» Analyze complaints and nonconformities- «BusinessProcess» Block nonconform components or products
- «BusinessProcess» Do QA review
- «BusinessProcess» Manage CAPAs
- Manage CAPA process
«Activity» Create CAPA- «Activity» Define CAPA activities, responsibilites and timeline
- «Activity» Define FSCA notice
- «Activity» Do root cause analysis
- «Activity» Evaluate noncompliances and complaints regarding required CAPA measures
- «Activity» Implement lesons learned in methods and procedures
- «Activity» Inform staff related to the CAPA
- «Activity» Verify / Validate CAPA effectiveness
«EndEvent» CAPA assessment complete
«StartEvent» New feed into issue tracker
«Gateway» CAPA required?- «Gateway» FSCA required?
- «BusinessProcess» Manage blocked parts or products
- «BusinessProcess» Audit supplier
- QM_Quality Management
- RA_Regulatory Affairs
- RM_Risk Management
- «BusinessProcess» Plan resources and budget Q&R
- «BusinessProcess» Report Q&R
- Clinical Marketing
- Research and Development
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox