Group: Komax AG
Catalog excerpts
Validated systems for pharmaceutical environments Thermo Scientific Evolution Series UV-Visible Spectrophotometers
Open the catalog to page 1Advanced tools for pharmaceuticals and high-value QA/QC testing For over 60 years, customers in world-renowned research, QA/QC and educational laboratories have relied on the high-performance and exceptional value provided by Thermo Scientific™ UV-Visible spectrophotometers. The Thermo Scientific™ Evolution™ One and One Plus UV-Visible Spectrophotometers provide simplified workflows; cuttingedge technology and an array of accessories to consistently deliver the high-quality results you depend on. If advanced performance and additional operational flexibility is required, The Thermo...
Open the catalog to page 2Evolution UV-Visible pharmacopeia performance requirements Performance Verification at installation and at set intervals thereafter is required for UV-Visible spectrophotometers in regulated laboratories. In the pharmaceutical industry, national pharmacopoeias with international reach define specific performance levels for several criteria. With superior specifications the Evolution Pro meets the performance requirements for all global pharmacopoeias including United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP). The Evolution One series meets all...
Open the catalog to page 3Complete IQ/OQ Validation package Thermo Scientific™ Validator™ packages provide support for system qualification and validation activities for instruments, software and accessories. All of the documentation and reference materials needed to facilitate compliance of your Thermo Scientific spectrophotometer system with the requirements of FDA, GxP, ISO 9001:2008 and ISPE 2001 guidelines and regulations are included for your convenience. Validator packages streamline Installation Qualification (IQ), Operational Qualification (OQ) and assist in Performance Qualification (PQ) procedures and...
Open the catalog to page 4Integrated informatics solutions Laboratory informatics are a critical part of any laboratory, facilitating end-to-end traceability of samples and associated laboratory processes, providing a central repository for data and test results and ensuring regulatory compliance. Thermo Scientific Lab Information Management Systems (LIMS) deliver a complete informatics solution for method execution, laboratory and data management. In combination with our Laboratory Execution System (LES), Scientific Data Management System (SDMS) and Integration Manager (IM), Thermo Scientific LIMS deliver the most...
Open the catalog to page 5Complete pharma solution bundles available With various bundles available, we have the ideal configuration to meet every need. Each bundle will include: • Choice of Evolution UV-Visible spectrophotometer • Insight Pro with security software • Validator for Insight Pro IQ/OQ Qualification Documentation • Choice of USP and EP Standards Set or general Qualification Filter Kit ecklist ible instrumentation ch Pharma UV-Vis ance requirements ☑ ☑ IQ/OQ qualification package ☑ Validated installation ☑ 21CFR Part 11 for data integrity ☑ LIMS compatibility ☑ Advanced QA/QC software functionality...
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