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

Significance of the topic

Adherence to FDA 21 CFR Part 11 is essential for laboratories and manufacturers relying on electronic records and signatures. It ensures data integrity, traceability, and regulatory acceptance, supporting quality assurance in pharmaceutical and chemical analysis.

Objectives and Study Overview

• Describe how Shimadzu LabSolutions Database and Client/Server software addresses Part 11 requirements
• Map software features to specific regulatory controls for closed systems
• Provide guidance on configuration and validation for compliance

Methodology and Instrumentation

Shimadzu conducted a detailed analysis of Part 11 provisions and implemented software functions to satisfy each control. User management, audit trails, electronic signatures, data protection, and report generation were developed in concert with SQL Server and Windows security environments.

Instrumentation Used

• LabSolutions Database and Client/Server software
• Windows XP/7/10 professional (NTFS formatted)
• Microsoft SQL Server database
• Shimadzu analytical systems (HPLC, GC, LCMS, ICPMS, UV, FTIR, balances, etc.)

Main Results and Discussion

• Closed system controls: validated installation and operation qualifications, access restriction, audit trails, and encryption support
• Electronic records: complete metadata storage, rapid retrieval, and human readable and electronic export formats
• Electronic signatures: two-component ID and password, signature manifestations with name, time, and role, and linkage to records
• Password management: uniqueness, periodic expiration, account lockout, and administrative reset
• Audit trails: automated logs for data actions, system administration, and user authentication stored in a secure database

Benefits and Practical Applications

LabSolutions enables laboratories to establish a closed environment meeting Part 11 criteria, simplifying computer system validation, strengthening data security, and improving audit readiness. It supports multi-instrument integration and centralized data management.

Future Trends and Opportunities

Emerging trends include cloud-based certified environments, advanced biometrics for signature controls, enhanced AI-driven audit analytics, and expanded interoperability with laboratory information management systems.

Conclusion

Shimadzu LabSolutions Database and Client/Server software provide comprehensive features to achieve FDA 21 CFR Part 11 compliance. By aligning technical controls with regulatory requirements, it facilitates reliable electronic data management and supports regulatory inspections.

Reference

• Shimadzu Corporation. LabSolutions Software Databases & Client/Server Version. Technical Controls for 21 CFR Part 11 Compliance. Revision 2.0, 2018.