Empower Tips Ask Me Anything About Managing Computerized System Risk at Data Integrity

The webinar focuses on how regulated laboratories can manage computerized system risks, strengthen data integrity, and maintain audit readiness. It discusses practical ways to use Waters Empower CDS to support controlled laboratory workflows and align with regulatory expectations such as FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.

Key Points from the Webinar

• Data integrity is an ongoing responsibility, not simply something to address before an audit.
• Computerized system risks need to be identified and controlled to prevent data integrity issues and regulatory concerns.
• Empower CDS configuration plays an important role in controlling how laboratory data is created, processed, reviewed, and managed.
• Maintaining an electronic chain of custody helps ensure laboratory data remains traceable throughout its lifecycle.
• Audit trails and appropriate system controls are important for monitoring activities and supporting audit readiness.

The goal is not just to pass an audit—it is to build a laboratory environment where data integrity and compliance are maintained continuously.