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

Importance of the Topic

Compliance with FDA 21 CFR Part 11 is critical in regulated analytical laboratories to ensure electronic records and signatures are trustworthy, reliable, and equivalent to paper documentation. Implementing robust software controls streamlines audits, maintains data integrity, and supports regulatory submissions.

Objectives and Overview of the Document

This technical note describes how Shimadzu’s LabSolutions Database and Client/Server software meet and support FDA 21 CFR Part 11 requirements. It aligns the regulation’s provisions with software functions to help users achieve a compliant, closed‐system environment for diverse analytical instruments.

Methodology and Implementation

• System Architecture and Validation
  Closed‐system configuration under Windows and SQL Server with Installation and Operational Qualification protocols to verify accuracy, reliability, and detection of altered records.
• Data Management
  Secure SQL database stores raw data, methods, metadata, and audit trails. Archive to removable media enables full recovery and long‐term retention.
• User and Access Controls
  Unique user IDs and passwords enforced by length, expiry, and lockout policies. Role‐based authority checks restrict functions and device interactions.
• Audit Trails and Electronic Signatures
  Automatic, time‐stamped logs for data operations, system events, and user authentication. Electronic signatures combine User ID and password, capture signer name, date/time, and approval meaning, and are indelibly linked to records.
• System Integrity Checks
  Instrument configuration validation, unit serial number verification, and sequence enforcement via predefined methods and schedules.

Main Features and Discussion

Shimadzu LabSolutions provides comprehensive 21 CFR Part 11 controls for closed systems, including validation support, data export in human‐readable and machine‐readable formats, protection against unauthorized modification, and detailed audit capabilities. The software’s modular logs isolate data operations, system administration, and user management for transparent traceability.

Benefits and Practical Applications

Using LabSolutions software helps laboratories:

• Maintain regulatory compliance and streamline audits.
• Protect data integrity with tamper‐evident records and robust backup strategies.
• Enforce user accountability and procedural consistency.
• Generate complete reports for regulatory submission and review.

Used Instrumentation

Shimadzu LabSolutions Database and Client/Server software integrate with a broad range of instruments, including:

• HPLC, GC, LC-MS, GC-MS, ICP-MS
• UV-Vis, FTIR, RF spectrophotometers
• Balances, TOC analyzers, particle analyzers, thermal analyzers, EDX

Future Trends and Applications

Advancements in cloud‐based data management, enhanced encryption standards, and AI‐driven audit analysis will further improve regulatory compliance workflows. Integration with laboratory information management systems (LIMS) and real‐time monitoring platforms is expected to expand, supporting remote audits and predictive quality control.

Conclusion

Shimadzu LabSolutions Database and Client/Server software deliver an FDA 21 CFR Part 11‐compliant environment through validated functionality, secure data handling, and comprehensive audit trails. These capabilities enable reliable electronic records and signatures, reinforcing data integrity and regulatory confidence.