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LC Software
Total Solution for PIC/S and FDA Compliance
All Shimadzu network system products incorporate functions for the PIC/S GMP and the Part 11 compliance regulation, and computerized system validation functions required by GxP. Shimadzu provides documentation including IQ/OQ, Certificates of Compliance, and Inspection Test Result Reports based on Shimadzu IS09001 certified system. Shimadzu's accredited service personnel offer full support for validation of customer's Shimadzu products. In the latest information on PIC/S and FDA regulations through seminars and workshops, participating in vendor audits demanded by agencies, and actively assisting customers to comply with new regulations.
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Field Meter
EFM-022
• This electrostatic field meter EFM022 is a hand-held field meter for precise measurement of electrostatic charges.• With the CPS022 accessory, the electrostatic field meter can be used as a charge plate monitor.• Precise measurement of static charges with automatic distance conversion (choice of 5 pre-set distances)• Operates on battery that can be supplemented with an AC net adaptor• With optional CPS022, can be used as a charge plate monitor for audit purposes and checking of ionization appliances
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Torque Screwdrivers
From better product quality to a lower total cost of ownership to guaranteed regulatory compliance, you can have it all with market leading Mountz torque screwdrivers. Built-in cam-over mechanisms prevent over and under-torque conditions so you can count on the quality of your work. Assembly and repairs performed with Mountz torque screwdrivers allows any user to deliver precision torque control with confidence regardless of task and operator skill level. And when it's time for compliance inspections or audits, equipment calibration records provide clear documentation. In short, Mountz torque screwdrivers keep your operation tight.
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Workstation Software
LabSolutions Balance
When connected to an analytical balance, LabSolutions Balance can be used to perform all processes automatically, such as calculating weighing results, and then save the weighing results in a LabSolutions database. Consequently, it eliminates the need for hand-written records and eliminates transcription errors. The software not only records sample information and results, but also protects data from malicious alteration and unintended overwriting or deletion and saves all audit trail information in a LabSolutions database. Furthermore, balance measurement data can be loaded during LabSolutions LC/GC batch analysis to create user-customizable analysis reports or for integrated data management by connecting to a LabSolutions CS integrated network system that includes non-Shimadzu equipment.
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Plant Auditor's Surface Resistance Kit
PMK-153
The PMK-153 Resistance Test Kit contains the instruments you need to take resistance measurements.The PMK-153 includes the PAS-853B Wide Range Ohmmeter with 5 pound Conductive Rubber Electrodes. The PAS-853B instrument is a wide range ohmmeter that measures accurately from 0.01 to 9.9x1012 ohms. In AUTO mode the instrument automatically adjusts resistance range and selects test voltage in accordance with standard practices outlined in ANSI/ESD STM11.11, and meets audit requirements of ESD TR53.
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Expert-Level Vulnerability Assessments
Vanguard Analyzer
Vanguard Integrity Professionals
Vanguard Analyzer™ provides Vanguard expertise on z/OS Security Server. Analyzer delivers expert-level vulnerability assessments of z/OS Security Server configuration controls and security settings with the ability to produce audit results in minutes. Vanguard Analyzer™ provides risk analysis and mitigation requirements in easy to read panels. System auditors can review Analyzer findings in order of priority and mitigate accordingly. Do you have access to expert-level assessment based on severity and vulnerabilities? Are your security analyst armed with invaluable interpretation of assessment findings? Can you provide your company with a detailed explanation, easy to understand risk statements and corrective actions that need to be followed step-by-step?
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USB Reusable Temperature and Humidity Data Logger
This reusable logger can monitor temperature and humidity in facilities, storage and processing areas, clean rooms, labs, and during transport. It is equipped with an external sharp tip probe, providing the option to monitor internal core temperature. Data is available in PDF or spreadsheet format and used for various purposes, such as process or equipment verification and validation, thermal mapping, and documenting environmental conditions to meet GMP, GDP and regulatory compliance. Reports are analyzed to identify trends and patterns, and management decisions can be made to improve practices in areas such as processing and cold chain logistics. Data is easy to archive for record keeping, audits, and compliance with FDA, CDC, HACCP, FSMA and other regulatory requirements.
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Wide Range Ohmmeter
PAS-853B
- Wide Resistance Measurement Range from 0.01 ohm to 9.99x1012 ohms- Nominal Full Range Tolerance Averages <±5%- Fully Automatic Resistance Range, Test Voltage and Electrification Period Control- Automatic or Continuous Electrification ControlRugged High Performance 80 inches (200cm) Test Leads Included- Powered by one long lasting 9V Alkaline Battery- Large, Easy to Read LCD Display- Meets requirements of ESD Association Standards for material and audit resistance measurement requirements- Certificate of Calibration Traceable to NIST included
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400A True RMS AC/DC Watt Clamp-on - Measures Watts, Current, and Voltage
Extech 380940
Extech Instruments Corporation
The compact Extech 380940 is a 400 Amp mini True RMS AC/DC power clamp meter with a small diameter jaw designed to reach in small areas while providing power calculations up to 240kW. With the added convenience of instant watt readings, a feature normally reserved for full-size meters, this mini power clamp is useful for essential troubleshooting tasks in plant maintenance, electrical, HVAC, and telecom work, as well as residential electrical repairs, energy audits, fleet maintenance, marine, and motorcycle repair. Complete with test leads, 2 AA batteries, and carrying case.
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Trace-Level Photometric Ozone Calibrator
Model T703U
Teledyne Advanced Pollution Instrumentation
The Model T703U is a microprocessor controlled ozone calibrator for precision gas analyzers. Expanded ozone audit levels have created a need for precise ozone calibration well below the capabilities of standard calibrators. The Model T703U is designed to meet the requirements of ultra-low ozone production.In addition to a high range with similar performance to the Model T703, the Model T703U has the capability to generate ozone in a low range, or "fractional" mode, for producing ozone levels down to 3 ppb, with exceptional accuracy. Flow rate and lamp intensity are adjusted to deliver a specified ozone concentration by volume. The temperature and pressure compensated photometer, identical to that of the Model T400 ozone analyzer, provides feedback control of the UV lamp intensity, assuring stable ozone output. A nearly unlimited number of calibration sequences may be programmed into the non-volatile memory of the T703U, covering time periods up to a year.
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SOP Managemen and Quality Management
arivis BM-Windream
BM-windream is the 21 CFR Part 11 compliant data and document management system for the pharmaceutical industry. It is based on the market leading windream document management system from windream GmbH, Bochum. In addition to our industry-specific modules, we have access to a series of tried and tested windream add-on modules from our partner network, e.g. for e-mail archiving, linking to ERP systems, CRM systems, knowledge management or scanning solutions. BM-windream provides a basis for your data and document management that can be validated at relatively low cost (configurable standard software complying with GAMP5) and is easy to use. Users access your documents using a virtual network drive in Windows Explorer, which means that little training is required. BM-windream provides a standardised user interface over the entire life cycle of a file, from creation to deletion. At all phases in this life cycle, a change history (audit trail) is recorded. BM-windream is suitable for handling all kinds of non-managed documents. BM-Flow integrates directly with BM-windream and provides the document management functions required for SOP management,manufacturing instructions etc. All general employees can then still access the documents using the familiar Windows Explorer, while those responsible for creating documents can also use the workflow interface in BM-Flow.
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HBM Verification Tester
HBM-VT
High Power Pulse Instruments GmbH
- HBM pulse generator verification tester according ANSI/ESDA/JEDEC JS-001 up to ±10kV- To be used in HBM test and qualification labs for regular pulse generator specification compliance test in order to fulfill lab audit and certification requirements- Fully automatic compliance test and verification of HBM pulse generators regarding ANSI/ESDA/JEDEC JS-001 normative standard at 3 different load conditions: Short Circuit, 500 Ω, and a reference diode at VBR=15 V reverse breakdown voltage, including DC test- Parameter evaluation and verification of the transient HBM current waveforms: Peak Current, Rise Time, Decay Time, Maximum Ringing Current- Optionally available upgrade for all HPPI TLP-3010C, 4010C, 8010A, 8010C, HBM-TS10-A hardware systems in combination with HBM-S1-B (6kV) pulse generators (upgrade on request)- Fully automatic test report generation (PDF)- Electrically floating (no fixed system ground): The HBM loads, current sensor output, USB control interface and the enclosure are electrically floating. There is no limiting system ground which may introduce common-mode interference induced HBM current measurement errors.- Isolated industrial full-speed USB control interface- Isolated power supply derived from USB port- Compact size 126mm x 82.5mm x 44.5mm
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Non Destructive Testing (NDT)
NDT covers a wide group of testing techniques used to evaluate the properties of a material, part, product, weld or system without causing damage. NDT carried out at KLL includes:Liquid Penetrant Testing (LPT) is used for the detection of surface breaking discontinuities on magnetic and non-magnetic metallic materials.Fluorescent and colour contrast penetrants are available to be used in the following methods:-Water washableSolvent removablePost emulsifiableMagnetic Particle Inspection (MT/MPI) is used for the detection of surface breaking and slightly sub-surface (up to 2mm) discontinuities.Bench type crack detectors and portable units are employed producing various waveforms (i.e. A.C, HWDC and induced magnetic flow) to give both circular and longitudinal magnetism.On-site testing is carried out using electro magnetic yokes and permanent magnets producing induced magnetic flow.Ultrasonic Flaw Detection (UT), also known as Ultrasonic Inspection, is used for the detection of volumetric discontinuities in ferrous and non-ferrous products (forgings and castings etc.), and welds in magnetic and non-magnetic materials.UT is capable of penetrating metals, dependent on the material characteristics, up to 10m in length.Some thickness and depth checks can also be carried out using ultrasound.Radiography services are available through sub-contract booked in advance. Notice is required for on-site work.Personnel are available at short notice for in-house or on-site work in the UK and overseas.All inspectors undertaking non destructive testing (LPT, MT/MPI and UT) are qualified to, and meet a minimum of, PCN Level 2.PCN Level 3 supervision is available in-house for LPT, MT/MPI, UT offering consultancy services including procedure writing and commentary, auditing of techniques and Level 3 Supervisor cover.We can assist clients in product qualification, material testing, quality assurance and audit programmes.
