Page 22 - Shimadzu’s Solutions for Impurities Analysis

Support from Shimadzu
Data Management
CLASS-Agent

˙ Requirements of Electronic ˙ Response to Electronic
Records/Electronic Records/Electronic
Signatures (ER/ES) Signatures (ER/ES) Regulations
Regulations by CLASS-Agent

FDA 21 CFR Part 11 and Japanese Ministry of Health, Labor The basic Shimadzu policy is to introduce compliance with
and Welfare policies on electronic records/electronic ER/ES regulations for all analytical instruments in the
signatures prescribe requirements for replacing conventional laboratory, including chromatographs (LC, GC, LC/MS, GC/MS,
paper-based records with electronic ones. Software must etc.), spectrophotometers (UV, FTIR, AA, etc.), total organic
provide sound security to ensure data integrity, allowing the carbon analyzers (TOC), thermal analyzers, and electronic
FDA Regulations on
Genotoxic Impurities
data to be reproduced at any time and preventing balances. It advocates products and technologies required for
overwriting, revising, or deleting the collected raw data. It compliance with ER/ES regulations for all data generated in
must also provide an audit trail that clarifies who did what the laboratory, based on CLASS-Agent.
operation and when.

˙ The CLASS-Agent Features

CLASS-Agent securely and integrally controls the analytical
ɾ entire laboratory.
instrument data in a database. Registered data can be easily ɾ
Moreover, CLASS-Agent Report simplifies report generation and
searched and browsed and an electronic signature can be achieves compliance with ER/ES regulations by eliminating the
Residual Solvents
®
applied, according to the purpose. need for manual data entry into Microsoft Excel and by
FDA Regulations on
Data obtained by the analytical instruments can be browsed,
ɾ providing electronic management as required by the ER/ES
electronically signed, and backed up by a single CLASS-Agent regulations.
Manager to provide efficient control of electronic data in the
Database management
Machine-readable
Chromatogram
Quantitation results
Methods
Schedules
Other data files
Human-readable Chromatogram review
Andi files Results display
PDF files Client PC Statistical analysis
Authorization by
electronic signature
FDA Regulations on
Inorganic Impurities
Database server Report generation
(public document)
Client PC
HPLC Printer
Office
GCMS
HPLC
RS-232C cable
GC
UV RS-232C cable Laboratory
Balance
Balance

Support from Shimadzu
Regulation-Compliant Network System Using
CLASS-Agent (Example)

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