Master Information Management
LIMSsolution registers analytical instrument information, report information, component information, analytical measurement parameter information, and so on, as master information and creates master test information from each list of master information.
Before tests are executed, test information must be registered, such as the analytical instrument used, target components, units, measurement parameters, person/department requesting test, and group in charge of analysis. Tests are executed by indicating the registered test information.
Test acceptance allows accepting scheduled tests, one-time tests, and tests instructed by the host computer. Note) It is also possible to schedule tests in advance according to a calendar. It is easy to confirm the acceptance status for a given period, request a re-test of tests already accepted, or perform many other tasks.
Note: Host tests are based on test instruction information indicated by the production management system or other such systems.
Automatic Creation of Batch Table Files
Based on information sent from test acceptance (test instruction information), LIMSsolution creates the batch tables necessary for Shimadzu LCsolution and GCsolution systems. Creating batch tables automatically helps prevent errors in entering important information. Created batch tables can be executed directly in the workstation or saved in a queue. Method files used by the workstation can be registered in a database as well and managed as a master database.
(Workstations capable of method management functions include LCsolution, GCsolution, and others.)
Analytical and measurement data managed by integrated management can be viewed or approved (or verified) using CLASS-Agent Manager software. Data can be searched based on information, such as sample information, registered during analysis or measurement. Data is verified by viewing sample information, data information, chromatogram viewer, spectrum viewer, PDF viewer, or other means.
Approved (or verified) data is automatically sent from the Agent database to the LIMSsolution database, where the necessary test results information is managed. (After the data is collected, it is also possible to send it to LIMSsolution without verifying or approving the data using CLASS-Agent.) If standard values or equations for calculations are registered in the LIMSsolution test master, it is possible to automatically perform calculations or determine pass/fail results and display the results.
Data is approved while CLASS-Agent results are verified.
Sophisticated Data Processing Functions
Based on the results from multiple instruments or results from an analytical instrument plus weight values measured on a balance, LIMSsolution can automatically perform multiple calculations using equations registered in a master table. LIMSsolution also offers other standard features, such as features that allow creating and printing inspection reports and daily reports, and features to create X-Rs control charts and summary tables, which are essential in the statistical process.
Manual Input and Customization Features
Data for the instruments or other equipment that cannot connect to LIMSsolution online can be registered by entering the data manually. Of the data parameters that constitute each set of test information, those parameters that may be customized are registered in advance. Then those parameters, such as lot number, acquisition location, or acquisition time, can be freely customized by user, such as by specifying the name or format.
Security and User Management for FDA 21 CFR Part 11 Compliance
LIMSsolution provides security features that ensure compliance with FDA 21 CFR Part 11, such as user login control, audit trails, and secure data storage. In addition, user information for HPLC or GC systems can be managed together with LIMS user information, in a single location. It is also possible to restrict access by assigning each user access to a group of features. To Detailed Description