August 9, 2017 | News & Notices LabSolutions Analytical Data System Updated with
Stronger Data Integrity for Spectrophotometers

Shimadzu announces the release of updates to its LabSolutions analytical data management system. The current update adds support for three types of Shimadzu spectrophotometers: ultraviolet-visible (UV-Vis) spectrophotometers, Fourier transform infrared (FTIR) spectrophotometers, and spectrofluorophotometers. These systems join a lineup that includes high performance liquid chromatographs (HPLC) and gas chromatographs (GC). The update also provides improved data integrity. This increase in supported models is expected to reduce operator workload and improve data reliability.

The LabSolutions analytical data management system is used to control and manage connected Shimadzu analytical instruments. The software features Shimadzu's Report Set function, unique functionality for customers performing pharmaceutical quality testing, for example. LabSolutions automatically prepares reports by gathering various information required for reviewing data, such as analytical instrument operation records, analytical results, and analytical conditions, and then saves the reports in a secure database.

Shimadzu is committed to using its strength as a manufacturer of a broad range of analytical instruments to promote the integrated management of instruments.

Background of the Update

Pharmaceutical quality must be tested properly using pre-specified procedures, and the analytical data and test results obtained must be managed appropriately in accordance with good manufacturing practices (GMP), as specified in the Japanese Ministry of Health, Labour and Welfare Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs. Furthermore, the United States Food and Drug Administration (FDA) and other agencies responsible for inspecting and investigating the pharmaceutical manufacturing industry require data integrity to ensure the reliability of pharmaceutical testing.

To certify that the tests themselves were performed properly, pharmaceutical companies must save analytical data, test records, instrument usage records, and so on, and manage the analytical data and test records in accordance with regulations on electronic records and electronic signatures specified by the FDA in 21 CFR Part 11.

The Report Set function in Shimadzu's LabSolutions analytical data management system has helped improve the efficiency and ensure the reliability of such processes for HPLC and GC systems and has earned excellent reviews from pharmaceutical companies. However, Shimadzu also received many requests for expanding the scope of instrument models supported by the functionality. In response to such customer needs, Shimadzu now offers support for widely used spectrophotometers.

Features of the LabSolutions Report Set Function

By simply selecting analytical data and report set creation on the menu, the LabSolutions Report Set function automatically gathers various applicable information related to analytical data (such as analytical conditions, parameter settings, and audit trail information) and summarizes it in a report. The gathered information is then securely saved in a database. In addition to preventing falsification of data, this function also improves the efficiency of reviewing test results. Some customers reported that the function reduced the time spent on the entire series of tasks involved, including reviewing the spectrophotometer, to one tenth of the time required without the function.

Shimadzu Spectrophotometers with the Report Set Function

- UV-VIS-NIR spectrophotometers controllable by UVProbe control software
- Fourier transform infrared spectrophotometers controllable by LabSolutions IR control software
- Spectrofluorophotometers controllable by LabSolutions RF control software

For more details, visit
Enhanced Functions of LabSolutions DBCS for UV/IR/RF Models