Data Integrity Compliance Using the LabSolutions Report Set

Importance of the Topic

Ensuring the integrity of analytical data is foundational for reliable decision-making in regulated industries. Recent incidents of data modification—whether inadvertent or deliberate—have attracted increased regulatory scrutiny, especially from the FDA. Robust mechanisms to record, lock and review every step of an analytical workflow are now essential to meet modern compliance requirements and to safeguard product quality and patient safety.

Objectives and Study Overview

This report examines the new Report Set function introduced in LabSolutions DB/CS version 6.50. The goal is to demonstrate how this feature enhances visibility of software operations, prevents data tampering and streamlines the review process. Key outcomes include reduced manual effort and improved audit readiness.

Methodology and Instrumentation

The study reviews typical HPLC workflows—covering sample preparation, instrument parameter setting, data acquisition, peak integration and batch processing—and identifies gaps in manual and print-based review practices. The Report Set function’s PDF consolidation and digital linking mechanisms are analyzed to show how they capture each human intervention and lock electronic records.

Main Results and Discussion

Three principal features of the Report Set function were evaluated:

• Visibility: Batch analysis reports, operation logs and chromatograms are merged into a single PDF, enabling reviewers to navigate a chronological “electronic book” of all activities without toggling between windows.
• Integrity Protection: A digital link between the PDF and underlying data files is automatically generated, preventing any modification, deletion or replacement of results.
• Paperless Workflow: Integrated electronic signatures allow concurrent approval of both the report PDF and the source data, eliminating the need for printed binders and manual sign-offs. This change cuts review time by up to two-thirds.

Benefits and Practical Applications

• Reduced review workload and storage overhead by consolidating all relevant reports.
• Stronger evidentiary trail for audits, fulfilling FDA’s enhanced focus on data integrity during pre-approval inspections.
• Streamlined CSV process, since the Report Set function is delivered as part of the LabSolutions package.

Future Trends and Potential Uses

As regulatory expectations continue to evolve, full digitalization of analytical workflows will become standard. Future extensions may include real-time dashboard monitoring of data integrity metrics, automated anomaly detection via AI and expanded integration with laboratory information management systems (LIMS). Such advancements will further accelerate compliance and drive efficiency.

Conclusion

LabSolutions DB/CS Report Set provides a comprehensive solution for data integrity compliance, combining visibility, tamper-proofing and electronic signature capabilities in a single, easy-to-use feature. Adoption of this technology supports faster, more reliable review cycles and aligns laboratories with rigorous regulatory standards.

Instrumentation

• Shimadzu LabSolutions DB/CS version 6.50 software
• High-performance liquid chromatography (HPLC) system

References

1. ORA FOIA Electronic Reading Room. July 6, 2005. FDA. URL accessed March 7, 2016.
2. McDowall RD. Quality Assurance Journal. 2006;10(1):15–20. doi:10.1002/qaj.357.
3. U.S. Department of Justice Press Release. March 8, 2007. FDA Criminal Investigations.
4. European Compliance Academy (ECA) GMP News. “Data Integrity: New Inspection Focus of the FDA.” February 25, 2015.
5. Paul Smith. “Data Integrity in the Analytical Laboratory.” Pharmaceutical Technology. May 2, 2014.
6. Bansho K. Chapter 5 Operations and Management for Paper‐Based and Electronic Data. Science & Technology; May 15, 2015:127–146.