Qualification and Validation
Qualification and Validation of networked systems are required by regulations, standards and policies for proper compliance.
Although network systems are specifically not mentioned within FDA validation documents, warning letters and observation reports show increasing evidence that they are looking for these systems to be validated.
Using GxP guidelines i.e. cGMP (current Good Manufacturing Practice), GAMP (Good Automated Manufacturing Practices) and 21 CFR Part 11 compliancy, Kazio Networks can help you:
• Write your validation plan
• Carry out vendor assessments
• Qualify your network system using the standard lifecycle 4Q model approach
• Validate your network systems
Other Service Offerings
• Network Design
• Network Analysis and Baselining
• Network Maintenance
• Network Management
• Network Validation and Qualification
• Consulting