Shimadzu LabSolutions Software - Technical Controls built-in LabSolutions for 21 CFR Part 11 Compliance

Importance of the topic

Shimadzu LabSolutions provides integrated data management for a wide range of analytical instruments while embedding technical controls that support compliance with FDA 21 CFR Part 11. This regulation defines criteria for trustworthy and reliable electronic records and electronic signatures, ensuring they are equivalent to paper records with handwritten signatures. Effective implementation of Part 11 controls is essential for laboratories in pharmaceutical, biotechnology, food, and chemical industries to maintain data integrity and to pass regulatory inspections.

Objectives and Study Overview

This summary reviews the structure and key requirements of FDA 21 CFR Part 11 and describes how Shimadzu LabSolutions Database and Client/Server software address each provision. It outlines system validation, user authentication, data protection, audit trail management, electronic signature implementation, and operational controls needed to create a closed system compliant with regulatory expectations.

Instrumentation Used

• Liquid and gas chromatographs (HPLC, GC)
• Mass spectrometers (LC–MS, GC–MS, ICP–MS)
• Spectroscopy systems (UV–Vis, FTIR, RF)
• Elemental and specialized analyzers (AA, TOC, particle analyzers, thermal analyzers, EDX)
• Analytical and precision balances

Main Results and Discussion

• System Validation: Installation Qualification (IQ) and Operational Qualification (OQ) protocols verify software accuracy, reliability and ability to detect altered records.
• Secure Data Storage: All analytical data, methods and audit trails are stored in an SQL Server database on an NTFS file system, supporting complete machine-readable and human-readable exports.
• User Authentication and Authorization: Unique User IDs and passwords, role-based permissions, password aging and lockout policies prevent unauthorized access.
• Audit Trails: Three independent logs (data operations, system administration events, user authentication changes) record date-time stamps for record creation, modification and deletion. Logs are immutable and retained for the regulatory retention period.
• Electronic Signatures: Dual-factor credentials (User ID and password) capture signer name, timestamp and signature meaning (approval, review, etc.), linking signatures irrevocably to records.
• Operational Controls: Predefined methods and schedules enforce correct sequencing. Device checks compare instrument configuration and serial numbers against stored method settings to prevent invalid operations.
• Record Protection and Retrieval: Archived data on removable media (e.g., CD-R) can be directly accessed and fully restored. Built-in search and recovery functions enable rapid retrieval throughout retention.

Benefits and Practical Applications of the Method

• Streamlines FDA Part 11 compliance by integrating controls directly into the data management software.
• Enhances data integrity and audit readiness, minimizing inspection risk.
• Simplifies both electronic and printed report generation with full traceability.
• Supports laboratory computer system validation and standard operating procedures.
• Centralizes multi-instrument data to ensure consistency across analytical platforms.

Future Trends and Possible Uses

Emerging developments may include cloud-based deployment models, blockchain or biometric enhancements for electronic signatures, deeper integration with laboratory information management systems (LIMS), and AI-driven audit trail analysis. Real-time compliance monitoring and secure remote access will address evolving requirements in decentralized and hybrid laboratory environments.

Conclusion

Shimadzu LabSolutions Database and Client/Server software offer a comprehensive closed-system framework for meeting FDA 21 CFR Part 11 requirements. Through validated installation, robust security, detailed audit trails and integrated electronic signature controls, the solution ensures data authenticity, integrity and reliability, simplifying regulatory compliance for laboratories.

References

• Shimadzu LabSolutions Software: Databases & Client/Server Version – Technical Controls for 21 CFR Part 11 Compliance, Shimadzu Corporation.