Durable Data for Non-IT: A Lab Manager’s Guide to Ensuring Your Empower Data Is Secure and Available from Creation Through the Full Mandated Retention Period

Importance of the Topic

Laboratory data are critical assets requiring stringent protection and retrieval capabilities to support compliance, product quality decisions, and to preserve the significant investment in data acquisition. Regulatory mandates necessitate retention of dynamic electronic data for defined periods, ensuring traceability and integrity from creation through mandated retention.

Aim and Overview of the Article

This guide outlines best practices for securing and maintaining Waters Empower CDS data. It covers risk-based strategies for backup and restore, archiving, disaster recovery, business continuity, system administration, and cybersecurity, focusing on non-IT audiences such as lab managers and QA/QC professionals.

Methodology and Instrumentation

Key methodologies include:

• Daily automated backups of Oracle databases via Waters Database Manager (WDM) and RMAN, plus raw data share backups.
• Archiving legacy projects using NuGenesis SDMS or Empower PLUS DM to offload data and preserve long-term retention.
• Restore testing in isolated environments to validate procedural accuracy and data integrity.
• High availability options (Oracle Data Guard, RAC), virtualization snapshots, and cloud storage for flexible recovery point and time objectives.
• Business continuity provisioning using BC LAC/E for offline analysis during network outages.

Main Results and Discussion

Effective data management reduces backup windows, storage costs, and restores times while improving system performance. Regular testing of backup and restore procedures is essential to ensure reliability during critical events. Archiving safeguards data integrity, streamlines active system performance, and simplifies regulatory audits. Cloud adoption offers scalability and offsite resilience but requires careful assessment of connectivity, security, and service agreements.

Benefits and Practical Applications

• Regulatory compliance through verified data retention and integrity controls.
• Cost optimization by archiving infrequently accessed data and reducing server load.
• Enhanced resilience via redundant backups, high availability, and disaster recovery plans.
• Continuity of laboratory operations using BC LAC/E during network failures.

Future Trends and Opportunities

The integration of cloud-native architectures, automated policy-driven archiving, and artificial intelligence for predictive disaster recovery are emerging. Standardized data lakes and containerized deployments promise greater flexibility, while evolving cybersecurity frameworks will further strengthen laboratory IT environments.

Conclusion

A robust data lifecycle strategy for Waters Empower CDS—spanning backup, archiving, disaster recovery, and cybersecurity—ensures that regulated laboratory data remain secure, available, and compliant throughout their mandated retention period. Proactive planning, routine testing, and leveraging modern IT solutions are key to mitigating risks and maintaining operational continuity.

Used Instrumentation

• Waters Empower Chromatography Data System (CDS)
• Waters Database Manager (WDM) with Oracle RMAN backups
• NuGenesis Laboratory Management System (LMS) and SecureSync
• Empower PLUS Data Management (DM) archive solution
• BC LAC/E and SecureSync for offline analysis
• Windows Scheduler, virtualization platforms, and cloud services (AWS, Azure, etc.)

References

• ISPE GAMP 5: A Risk-Based Approach to Operation of GxP Computerized Systems, ISPE, 2009.
• EU and PIC/S Good Manufacturing Practice Annex 11.
• PIC/S Guidance PI-041-1: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, 2018.
• WHO TRS 966 Annex 5: Guidance on Good Data and Record Management Practices, 2016.
• Waters Corporation Policy on Microsoft Hotfix Testing with Waters Software.
• Public GxP Compliance Statements by Major Cloud Providers.