Data Integrity Compliance Using the LabSolutions Report Set

Importance of the Topic

Analytical data integrity underpins the reliability of laboratory results and is a key requirement for pharmaceutical, food, and environmental testing. Recent regulatory actions by agencies such as the U.S. FDA have underscored the risks of unauthorized data modification or replacement, whether intentional or inadvertent, and have prompted tighter oversight of electronic record-keeping systems.

Objectives and Overview of the Article

This white paper examines common data integrity issues in chromatography laboratories and introduces the Report Set function provided in Shimadzu’s LabSolutions DB/CS version 6.50. The main objectives are to demonstrate how enhanced visibility of software operations can strengthen audit trails, reduce review times, and support regulatory compliance.

Methodology

The authors use high-performance liquid chromatography (HPLC) workflows to illustrate the relationship between input parameters (sample preparation, instrument and data-processing settings) and output results (chromatograms and batch reports). They analyze typical failure modes revealed by FDA inspections—such as shared logins, missing audit trails, and uninvestigated out-of-specification results—to define prerequisites for ensuring data integrity.

Instrumentation Used

Shimadzu LabSolutions DB/CS version 6.50 chromatography data system with Report Set functionality
High-performance liquid chromatography (HPLC) instrumentation integrated through LabSolutions software

Key Results and Discussion

The Report Set feature consolidates batch analysis reports, operational logs, and chromatogram reports into a single, digitally signed PDF. Three key improvements were demonstrated:

• Visibility of Operation Sequences: Users can review the entire chain of analysis steps in a single PDF “book,” eliminating time-consuming window switching.
• Automatic Data Locking: Once reports are linked to raw data, editing is locked, preventing unauthorized modification or deletion.
• Electronic Review and Approval: Built-in electronic signature workflows enable paperless confirmation of report content, further reducing manual printing, checking, and storage.

The implementation of Report Set cut data-review times by up to two-thirds compared to traditional print-and-sign procedures, while strengthening audit-trail compliance.

Benefits and Practical Applications

The Report Set function offers laboratories a streamlined, paperless workflow that enhances regulatory compliance and operational efficiency. Key benefits include:

• Reduced administrative burden through consolidated reporting and electronic signatures.
• Improved traceability of human-machine interactions for audit purposes.
• Lower storage costs by eliminating bulky print binders.
• Faster batch release decisions due to simplified review processes.

Future Trends and Potential Applications

As regulatory expectations for data integrity continue to rise, future developments are likely to focus on deeper integration of artificial intelligence for anomaly detection, broader support across diverse analytical platforms, and real-time monitoring dashboards that provide instant visibility into system operations. Adoption of cloud-based compliance solutions may further extend the capabilities of traditional laboratory information management systems.

Conclusion

The LabSolutions DB/CS Report Set feature provides a robust framework for ensuring the completeness, authenticity, and traceability of analytical data. By consolidating operational logs and analytical reports into a single, locked PDF with electronic signatures, laboratories can meet stringent regulatory requirements while significantly reducing the time and resources needed for manual review.

References

1. ORA FOIA Electronic Reading Room, U.S. Food and Drug Administration, July 2005.
2. R. D. McDowall, Quality Assurance Journal, 2006, 10(1), 15–20.
3. U.S. Department of Justice Press Release, FDA, March 2007.
4. European Compliance Academy (ECA), GMP News, February 2015.
5. Paul Smith, “Data Integrity in the Analytical Laboratory,” Pharmaceutical Technology, May 2014.
6. Keiko Bansho, Chapter 5 in Recording and Managing Data and Migration to Digitization at Laboratories Based on the Issues Raised by the Three Authorities, Science & Technology, May 2015, 127–146.