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CLASS Agent Integrated Data Management Software

CLASS Agent Integrated Data Management Software

The CLASS Agent software is a solution concept for FDA 21 CFR Part 11 compliance for analytical instrument data. All data generated by various analytical instruments, all related log files for user access and instrument operation are automatically transferred into an SQL® or Orcacle® database. Using the Archive Agent program, any files (documents, tables, etc.) can be also added to the database.

CLASS Agent manage data from the following instruments

  • Lab Solution software – direct import
  • CLASS VP Agent (for CLASS VP software version 4, 5, 6 and 7)
  • UV Probe Agent
  • IR Solution Agent
  • Public Agent (to import other data files / formats) into the database

Using the Public Agent which to specifies the datafile format (Gateway) before import into the database, allows implementation of other vendors instrument data.

For review of data, searches in the database and advanced report of the search results the Agent Manager software can be used. Electronic signatures can be applied in a multi stage approval mechanism.

The database contains the raw data file, method and sequence file and all related meta data. Beside the instrument data file format a human readable file is created (Chromatogram – AIA format, Spectra – JCAMP format); according to the local settings also the Adobe Acrobat ® *.pdf files can be included.

For search routines the relevant information from the datafile

  • Concentration
  • Retention time
  • Peak Area
  • or Peak Height etc.

are available. Powerful tools assist to create queries for database searches, a special report tool supports visualisation and presentation of the results.

User Administration is realised for all Agent software and some workstation software via the ‘Shimadzu User Authentication tool’, which allows to create new databases or link to existing database systems and define the general settings (password expiring date, user attempts etc.). User Levels are predefined, for the configuration of the Agent solution depend on the actual installation and laboratory workflow customised user levels are possible.

The CLASS Agent as concept for a laboratory wide solution for supporting FDA 21 CFR Part 11 compliance will be configured based upon the local requirements and instrumentation. Other vendors instrument data in a standard format can be included in the database.

Providing a scalable solution to FDA 21 CFR Part 11 compliance requirements to a wide range of laboratory instruments, including AA, TOC and UV-Vis, CLASS Agent Integrated Data Management software offers electronic signature and record, and secure database archiving for Shimadzu Instruments' control software packages.

Class VP 7 Software
Class VP 7 Software

CLASS VP 7 is the Client / Server version of the Chromatography software workstation package CLASS VP. The software for controls beside Shimadzu LC and GC instrument also other instruments in a network environment.

The software allow to store method and datafiles and additional comments and parameters (User name, Sample ID, data and time of acquisition) which can be later used to select one data file and start search procedures. By using the right mouse button it is now possible to get the user inter face more user friendly. In each instrument window the operator will find the same functionality, the most important functions can be accessed by toolbars such as the integration events, the integration event table and the peak table. For the integration the CLASS-VP and the Shimadzu Chromatopac algorithm are selectable.

The software provides numerous new Good Laboratory Practice (GLP) features, such as storage of results with data and method, file overwrite protection. For handling a method, an Audit trail option can be activated and will register all changes in the method with or without additional comments to the changes. A multi level individual user password security system takes care that different systems can only be accessed by authorized staff. An alteration check program verifies that all installed CLASS-VP program files have not been corrupted or altered. Additionally to these features, the CLASS VP 7 software supports features according to FDA 21 CFR Part 11 compliance such as audit trails for data, meta data file saving concept and electronic signature option.

CLASS VP software is compatible to the CLASS Agent software, which provides a laboratory wide solution concept for work under FDA 21 CFR part 11 compliance conditions.

The handling of sample sequences in done by a batch table, which contains all information for acquiring of standard calibration curves, running unknown samples as well as check the integrity of an calibration and the full chromatography system by special QC check samples or system suitability runs. The QC Check features verifies upper and lower QC limits. The QC limits can be set different for each peak in the method's ‘Peak table’ in the method. For the system suitability test for example the column performance data, repeatability, accuracy, noise or baseline drift can be used. Failure actions provides automated control of real time sequences allowing criteria such as re-injection of a sample if it is out of range to be set, or aborting a sequence if it does not meet the validation criteria. Repetitions from the same sample will be averaged by the software, for single level re-calibrations it is possible to re-calibrate different levels step by step or all together.

The configuration for each system is linked to the instrument window, ‘auto config’ functions and a connection wizard (CLASS VP 7) make it easier to add all necessary items for all modules. Following the VP concept, the serial number and firmware version is read out automatically, alert levels for the major spare parts such as plunger seals or detector lamps can be set, typical values therefore are recommended as default. For direct access to the main functions a special toolbar can be arranged on the screen. This allows to activate/inactivate of the system, to switch detector lamps on and off, to set the incoming signal at zero, to rinse or purge the autosampler; start or to stop pumps or column oven. CLASS-VP offers digital data exchange between LC modules and PC via the systemcontrollers SCL-10Avp, CBM-20A and CBM-20ALITE and between the GC instruments GC-2010 and GC-2014.

The VP functions, log files for all HPLC instruments will be checked by an ‘Validation run’, the system check report offers all information about all connected hardware components and the pass/fail judgement for the whole system.

An additional Status log provides continuous measurement of parameter condition during an analysis. Key parameter such as pump pressure, oven and ambient temperature create a permanent record of how a sample run. All of these parameters, existing data files or (and) the gradient profile can be overlaid over an running chromatogram so that you are informed about the current status of your system.

Flexible report editor: Customized analytical result reports can be prepared by the custom report functions; providing customisation of report fonts and colours, insertion of any bitmap images (your company logo, photos etc.) OLE compatibility to import graphs, charts, text documents etc. Summary report function provides calculation of % RSD of response factor, area and concentration as well a pass/fail judgement according to the result of the calculation.

Class VP 7 Client/Server software is designed to provide a regulatory compliant network solution to chromatography control, data analysis and storage. Including Method, Data and Sequence audit trails, status logs, QA/QC reports, electronic signatures, advanced system administration and many other features, it is the ideal solution to address 21 CFR part 11 issues.

Software-GC Solutions
Software-GC Solutions

Featuring "One-Window" functionality for ease of operation, a data explorer and batch table Wizard to improve productivity, and security support with multi-user level access. Validation and audit trail support, together with QA/QC functions and "all-in-one" file structure help GLP/GMP requirements. Together with comprehensive qualitative and quantitative functionality, powerful, highly flexible report generation and remote access and data management, GCsolution software is the perfect partner for Shimadzu GC systems.

 
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