What you should know to assure laboratory data integrity with LabSolutions

Significance of the Topic

Data integrity has become a top priority for life sciences laboratories as regulatory agencies worldwide intensify inspections and enforcement. Reliable data underpin product quality, patient safety and regulatory compliance. Ensuring that analytical results and raw data are accurate, complete, traceable and protected against unauthorized change is essential to maintain public trust and to avoid costly warning letters, import bans or product recalls.

Objectives and Overview of the Article

This white paper reviews the procedural, cultural and technical controls necessary to establish robust data integrity in regulated laboratories. It examines common inspection findings, highlights organizational and human factors that contribute to non-compliance, and outlines how Shimadzu’s LabSolutions CS analysis data management system and supporting instruments can satisfy requirements from global guidelines such as FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S and WHO.

Methodology and Used Instrumentation

The recommended approach combines risk-based validation of instruments and software, formal data governance, and comprehensive training and periodic review. Key steps include:

• Risk assessment and lifecycle modeling to identify critical data paths
• Qualification (IQ/OQ) of analytical instruments and infrastructure
• Performance qualification of LabSolutions CS to meet user requirements
• Implementation of SOPs for data entry, audit-trail review, change control and backup
• Segregation of duties and periodic account reviews
• Periodic data integrity audits and forensic data analysis

Used instrumentation and software:

• Shimadzu LabSolutions CS analysis data management system
• High-performance liquid chromatography (HPLC)
• Gas chromatography (GC)
• Ultraviolet, infrared and mass spectrometers
• Balances and standalone lab equipment
• Server or virtualized infrastructure with secure backup and archiving

Main Results and Discussion

Recent inspections have uncovered cases of record deletion, falsified trial runs, shared user accounts, disabled audit trails and missing backups. These failures often stem from organizational pressures, inadequate user training or poor culture rather than lack of technology alone. While standalone instruments are vulnerable to manipulation, an integrated, relational database approach in LabSolutions CS prevents unauthorized edits, enforces method locking, and retains comprehensive audit trails. LabSolutions CS features such as user role management, electronic signatures, encrypted communications and periodic review tools align with FDA Part 11 and EU Annex 11 requirements.

Benefits and Practical Applications

Adopting an integrated data management platform combined with strong procedural controls offers multiple advantages:

• Consistent electronic records with human-readable printouts
• Automated, time-stamped audit trails for raw data, methods and results
• Lockable validated methods and enforced change-control workflows
• Secure remote operations and centralized data archiving
• Streamlined compliance for inspections and regulatory submissions

Future Trends and Possible Applications

Data integrity strategies will increasingly leverage risk-based frameworks, artificial intelligence for anomaly detection, blockchain for immutable records, and cloud-based platforms with secure audit capabilities. Integration with enterprise systems (ERP, LIMS) and advanced forensic analytics will further strengthen proactive compliance and real-time monitoring.

Conclusion

Ensuring data integrity requires a holistic program encompassing organizational culture, procedural rigor and robust technical controls. Shimadzu’s LabSolutions CS and analytical instruments, when properly validated and configured, address the full spectrum of regulatory requirements and reinforce trust in laboratory data. By combining sound data governance with modern software features, laboratories can reduce risk, streamline operations and meet evolving global expectations.

References

1. UK “GXP Data Integrity Guidance and Definitions”, March 2018
2. US FDA “Data Integrity and Compliance with Drug CGMP”, December 2018
3. WHO “Guidance on Good Data and Record Management Practices”, Technical Report 996, May 2016
4. PIC/S “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments”, Draft, November 2018