| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 17.04.2014 15:44:28 |
| Modified: | 27.02.2018 10:22:55 |
| Advanced : | |
| Appears In: | Manage CAPA process, CFR 820.198 Complaint files, 8.3.3 Maßnahmen als Reaktion auf nach der Auslieferung festgestellte nichtkonforme Produkte, 8.3.2 Maßnahmen als Reaktion auf vor der Auslieferung festgestellte nichtkonforme Produkte, 8.3 Control of nonconforming product, Appraisal of individual data sets, 8.5.3 Preventive action, 3.2 Absatz 3 (b), 8.5.3 Vorbeugungsmaßnahmen, QA_Quality Assurance, CFR 820.100 Corrective and preventive action., Provide Hotline and SERVICE LEVEL 0 |
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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