Auditing Laboratory Data Systems 2019 is a webinar that covers topics such as:
- 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
Auditing Laboratory Data Systems 2019 is intended for:
- 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
