Page 14 - Shimadzu UV-1900i

Advanced Regulatory Compliance Compatible with Validation from PC Software

Full Support for Pharmacopeia, GLP/GMP, FDA 21 CFR Part 11 and Other Regulations Validation can be implemented with PC software by using the optionally available UV validation software.
In addition to simplifying daily inspections, this makes instrument performance checks and records management easier, enabling more
Instrument Validation Functions Compliant with JP, USP, and EP secure regulatory compliance.

This instrument can not only run checks for nine JIS items, but also those stipulated in the Japanese Pharmacopoeia (JP), United
States Pharmacopeia (USP), and the European Pharmacopoeia (EP). Naturally, the hardware is also compliant with the specifications
required by each Pharmacopeia. In addition, the check conditions can be saved. As a result, once the conditions are saved, checks can
be performed easily just by calling them up as needed. Check results can also be saved.

• Inspection results can not only be printed but also saved to a file, so the • The user can select confirmation of instrument performance indicators
results can be called up later for confirmation. as per JIS K0115 General rules for molecular absorptiometric analysis, as
• The inspection parameters can also be saved to separate files for well as the general test methods in the Japanese Pharmacopeia, USP
periodic and routine inspections, and then called up for use. and various EP inspections. (Order inspection jigs and reagents
Main Screen separately.)
Support for FDA 21 CFR Part 11, PIC/S GMP Guidelines and Other Regulations and Guidelines
Ensuring the integrity of data (database management), including the user management, user authority management, and data audit
trails required for compliance with FDA 21 CFR Part 11, PIC/S GMP guidelines, and other ER/ES regulations, is possible.

LabSolutions DB UV-Vis or UVProbe / LabSolutions DB System
The system allows for data management and user management
with a database. Compliant with ER/ES regulations, the system is
optimally configured for customers using a PC.
Parameters Setting Screen
LabSolutions CS UV-Vis or UVProbe / LabSolutions CS System (Network System)
The system is optimally configured for customers who want to manage data on a server together with LC and GC data for ER/ES
compliance.
Check Results Screen Analysis equipment LabSolutions server
Client PC room or an office

During Testing Screen

Improved Security Functions

An external control security function has been added to provide more support for
Acquisition
compliance with regulations. Three user authority levels, "Administrator", controller PC UV FTIR RF ICPMS
"Developer", and "Operator", can be set for instrument users.

Resolution of 1 nm, the Highest in its Class GCMS AA TOC

In addition to achieving a resolution of 1 nm, the highest in its class, by using a monochromator with a Czerny-Turner mounting, the EDX Particle size
analyzer
UV-1900i also features a compact, bright optical system. The instrument is more than capable of meeting the wavelength resolution Combine with Multi Data Registration license to enable
LC GC LC GC integrated management of these instruments’ data.
required in the European Pharmacopoeia.
UV-1900i
14 UV-VIS Spectrophotometer 15