Shimadzu Corporation has released LabSolutions CS Ver. 6.0 data analysis system. LabSolutions CS enables remote control of multiple LC (liquid chromatograph) and GC (gas chromatograph) units from any PC on a network. Analytical instruments can be controlled and analysis results can be monitored not only in the laboratory but also from a PC installed in a remote location. Data can also be integrally managed using a database. These functions can significantly improve work efficiency.

Development Background

LC and GC units are widely used in quality control and research and development departments of pharmaceutical companies and chemical and food manufacturers. In recent years, the need for analysis and measurement has increased in order to secure food safety and preserve the natural environment while international competition among corporate users has become fiercer. This has led to a significant increase in the number of samples being measured. As a result, the amount of data to be managed has likewise rapidly increased. Companies, especially ones in the pharmaceutical industry, are required to be compliant to regulations and guidelines such as CSV*, ER/ES Guideline** of the Ministry of Health, Labour and Welfare of Japan, and U.S. FDA 21 CFR Part11***, and to maintain and manage instruments and analysis data adequately and efficiently. This type of environment requires the ability to perform various types of analysis in a limited time and more efficient management of instruments and data. LabSolutions CS is a network-compatible data analysis system developed to satisfy these needs.

* Computerized system validation: An example is a new CSV guideline issued by the Ministry of Health, Labour and Welfare of Japan last October, “Guidelines for Adequate Management of Computerized Systems in Manufacturers and Suppliers of Pharmaceuticals and Quasi Drugs.”

** Guideline related to electronic records and signatures: Japanese version of ER/ES guidelines issued by the Ministry of Health, Labour and Welfare of Japan in 2005, “Guideline for Using Electromagnetic Records and Electronic Signatures for Applications for Approval or Licensing of Drugs”

*** The rule determined by the U.S. Food and Drug Administration (FDA) concerning requirements for electronic records and documents that pharmaceutical companies need to submit when applying for approval to sell drugs in the U.S.

Features of the New Product

(1) Comfortable Operating Environment

LabSolutions CS enables access from any PC connected to an established network to any LC or GC unit. For example, you can operate the instrument using a nearby PC before starting analysis. After analysis has begun, you can check and control the instrument’s operation status using a PC in the office. You no longer need to occupy a PC until analysis is finished or go back and forth between the office and laboratory to check analysis status.

Since analysis data is managed in a database on the server PC in an integrated fashion, data can be viewed or analyzed from any PC on the network.

(2) Safe, Secure Data Management

LabSolutions CS is equipped with a database function that prevents mistakes, such as incorrect overwriting or deletion of data, so that analysis data can be safely managed. A series of postrun analysis results are automatically saved and managed without overwriting. Therefore, results of postrun analyses performed in the past can be easily displayed or restored.

It is also equipped with a project management function where analysis data is sorted according to purpose, and users with access clearance can be specified in order to achieve a more flexible, robust security system.

(3) Expandable System

The optimal data analysis system is provided according to the customer’s business configuration and scale, from a standalone system where LC and GC units are controlled and data is analyzed using one PC to a large-scale network system where a great number of instruments located in multiple laboratories are controlled and data is analyzed and managed using multiple PCs.

When used in combination with CLASS-Agent, data acquired by multiple Shimadzu instruments, including LC/MS, GC/MS, UV, FTIR, AA, TOC, thermal analyzers, particle size analyzers, and balances in addition to LC and GC units, can be managed in an integrated fashion as long as these units are connected to the network. Moreover, data acquired by other manufacturers’ LC, GC, elution testing machines, and some other instruments can be managed as well

(4) Compliance with Regulations

LabSolutions CS is equipped with security and audit trail functions to ensure compliance with various regulations and guidelines, including the ER/ES guidelines determined by the Ministry of Health, Labour and Welfare of Japan, U.S. FDA 21 CFR Part11, and EU GMP Annex11.

Moreover, software installation information, system security policies, system configuration information, and user information can be viewed or printed from a single operation window, providing efficient CSV work required to be compliant with regulations.

Since LabSolutions CS runs under a terminal service environment, it can be operated in a thin client system where the software does not need to be installed on PCs. In this case, only the software on the server needs to be updated when a version update is necessary, which reduces validation work and system management costs.

Currently, individual software needs to be used for products other than LC and GC units. However, software will eventually be integrated with the LabSolutions Series for even more convenience.