Network-compatible data management tool, providing full support for FDA 21 CFR Part 11
Network-compatible Analysis Data Management Tool
The CLASS-Agent software conducts database management of various data files from HPLC, GC, GCMS, LCMS, FTIR, UV, and AA spectrophotometers, thermal analyzers, TOC, and electronic balances as well as images and text data.
Quick data searching and analyzing and approving laboratory data in the office help make laboratory work "Quick & Easy". Fingerprint verification and other powerful security measures comply with the Electronic Records and Electronic Signatures * Supplement to support "Safe & Sure management" of laboratory work.
Making Laboratory Work "Quick & Easy" (supporting more efficient laboratory work)
|I can't immediately find important files|
|There are so many analysis files and text files in my PC that I can't find the ones I need. That's a real problem.|
|Instantly find data|
|Data classification and automatic registration
Data searches with multiple keywords
|I want to analyze laboratory data at my office PC|
|I want to analyze and approve analysis data measured in the laboratory from my own office PC. If possible, I'd like to share data between remote work sites.|
|Browse laboratory data from remote locations|
|Analysis and approvals in the office
Browse data with a web browser
|It's always a struggle to compile data and create reports.|
|I use Excel® or Word® to compile multiple analysis results or results from different analytical instruments but manual input is subject to errors. It also takes a long time to compile large amounts of data.|
|Easy report generation|
|Display chromatograms and spectra
Display lists of multiple data
Smooth linking to Excel® and Word®
|It's inconvenient to manage data in separate PCs.|
|Data is managed in the PC connected to each analytical instrument. It is really inconvenient to compile data from multiple instruments for analysis. If the PC administrator is absent, it's sometimes impossible to browse data in a PC.|
|Data is compiled for data management|
|Central management of data from various instruments
Compatible with analytical instruments from other manufacturers
Supports Safe&Sure Management (support for ER/ES-compatibility *Supplement, including security control)
|I'd love to handle the large number of documents without paper|
|It's easy to forget where I stored a file in bookshelves and cabinets bulging with documents. Sometimes the file I need has been taken by someone else, and I can't use it.|
|Supports paperless operation|
|Registers PDF files with electronic signatures
Automatic registration of Excel® and other document and image data
|I don't know how to apply security to data.|
|I want to apply sophisticated security compliant with regulations, but I don't know how to go about it.|
|It's easy to apply strong security.|
|Central user management and access control
Fingerprint verification and other security measures
Automatic operation log recording.
Word® and Excel® are registered trademarks of Microsoft Corporation.
Supplement: What is FDA 21 CFR Part 11 Rule on Electronic Records and Signatures?
This rule on electronic records and electronic signatures applies to electronic records, electronic signatures, and electronically submitted items created based on tests conducted under the GLP/GCP (clinical)/GMP rules.
The Rule on Electronic Records and Signatures prescribes the requirements for converting conventional paper-based records to electronic media. Software must provide sound security to ensure data integrity that allows the data be reproduced at any time and prevents overwriting, revision, or deleting of the collected raw data. It must also provide an audit trail that clarifies who did what operation and when.