2023 - AUDITING LABORATORY DATA SYSTEMS

Ensure regulatory compliance and maintain data integrity through effective auditing of laboratory data systems. Join our informative webinar, where we delve into the crucial aspects of auditing to meet the expectations of regulatory agencies. Gain detailed insights into the most common non-conformances and equip staff members, even those unfamiliar with laboratory computer systems, with a comprehensive understanding of the necessary controls to ensure the integrity of analytical data.
This webinar is designed to educate participants on the importance of correct data system configuration and provide guidance on what to look for during the audit process. By implementing the knowledge gained, businesses can effectively reduce the risk of regulatory action resulting from non-compliance with current expectations, safeguarding their operations and reputation. Don't miss this invaluable opportunity to enhance your auditing practices and align with regulatory requirements.
AREAS COVERED IN THE SESSION:
Categories of laboratory data system (GAMP)
Lifecycle management, archiving and backup
What counts as raw data?
Protecting the integrity of analytical data
General guidance on assigning user privileges
Operating system configuration.
Application configuration
Controls appropriate for chromatography data systems
Practices that aid compliance with data integrity requirements
Examples from recent FDA warning letters
WHO SHOULD ATTEND:
Quality Assurance Departments
Quality Control Departments
Regulatory Affairs Departments
Research and Development Departments
Staff who are required to audit analytical operations who do not have a chemical QC background
Auditors who require updating on current regulatory expectations
QC staff who needs help in regulatory compliance
Staff who would like to understand the implications of data integrity for laboratory data systems