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QMS (Document Controls (Good Documentation Practices, Change Control for…
QMS
Document Controls
Good Documentation Practices
Change Control for Technical Documents
Material Creation Request
Configuration Management
Document owner/archive Matrix
Data drive disposal
Data backup
Creation of Validation Legal Documents:
Definition, creation and maintenance of DMR
Risk Management
Risk Analysis for Non-Product SW
Risk Plan
Risk Assessment
Risk Report
Post Market Surveillance
Health Hazard Evaluation
Facility and Equipment Controls (pest)
Test Equipment Calibration
Electrostatic Discharge
Good Lab Practice:
Facilities Maintenance
Work Area Final Assembly (not Leipzig)
Biological Safety and decontamination
Management Responsibility and Reviews
Internal Audits
Quality
Policy
Company Organisation
Chart
New Employee Training
Customer Excellence /User Information
Service Support Installation
Customer Change Notification
Work on Tenders
Development of Contracts
User Information - Functions and Responsibilities
Post Release Product LifeCycle Management
Field Action
Advertising and Promotional Material
Quality Management
Handbook
Purchasing Material Controls
Supplier Management:
Return of Instruments
Import/Export
Order Review & Processing
Order Processing
Order Fulfillment (shipping)
Conducting Supplier Audits
Electronic Request
Outsourcing
Contract Management
Clearing Inventory
Structures and approvals of products in ERP
Production & Process Controls
Process Validation
Non-Product SW
Validation Master plan: VMP
Data Analysis
Cleaning process
Mandatory process Validation
Product Inspection and Test
Label Controls
First Article Inspection
Production CARE
Special Incoming Inspection
Process Deviation
Receiving and Warehouse
Inventory Control
Corrective and Preventive Action
Control of Nonconforming Product
Defect Reporting
Creation & Management of D1/D2 Report
Material Return to Vendor
Supplier Corrective Action Report
Complaint Handling and MDR
Excursion/Event Process
Design Control (Phases)
Design Control (DDP)
Consumables Design V&V
Clinical Trails
Sample Size Selection
SW release
SW Design V&V
SW Master Build
Design verification master plan
Device Master Record index
Creation DMR
Last update: 2019-05-02