Auditing Laboratory Data Systems 2019

Topics

• Lifecycle management, archiving and backup
• Categories of laboratory data system (GAMP)
• Protecting the integrity of analytical data
• What counts as raw data?
• Operating system configuration
• General guidance on assigning user privileges
• Controls appropriate for chromatography data systems
• Application configuration
• Examples from recent FDA warning letters
• Practices that aid compliance with data integrity requirements

Who should Attend

• Auditors who require updating on current regulatory expectations
• Staff who are required to audit analytical operations who do not have a chemical QC background
• Staff who would like to understand the implications of data integrity for laboratory data systems
• QC staff who needs help in regulatory compliance