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Laboratory Systems/Instruments Compliance
CimQuest, Inc. provides regulatory compliance
consulting services to clients who need assistance
with their laboratory environments. Whither the need
is for validation of laboratory systems (e.g.
Laboratory Information Management Systems (*LIMS),
Chromatography Data Acquisition Systems)or
qualification of instruments, CimQuest can provide
skilled, experienced consultants to handle the work.
Many laboratories have discovered that they have
significant exposure relevant to compliance with 21
CFR Part 11, Electronic Records / Electronic
Signatures. Laboratories typically have many
instruments that generate large volumes of data. The
authenticity and reliability of this data must be
assured. We can assist your laboratory by conducting
a risk assessment that allows you to focus on the
critical systems and functions thereby saving you
time and money.
CimQuest has many years of proven compliance
consulting experience in all GXP laboratory
environments including QA/QC, R&D, Contract Labs,
and Clinical Testing. This experience means that you
have a trusted partner who understands laboratory
compliance.
Typical Lab Systems
• Most Major LIMS Validation (Thermo, LabWare,
Beckman-Coulter, LabSys, SQL*LIMS, LabVantage)
• Chromatography Data Systems (Waters, Agilent,
PeakPro, Turbochrome)
• Networked Data Acquisition Devices
• Laboratory Systems Interfaces
• Spreadsheet Validation
• Clinical Data Management Systems
• Document Management Systems
• Robotic Systems (Zymark, Tecan)
Typical Lab Instruments
• HPLC, GC / LC
• Mass Spec. / NMR
• FTIR, NIR, UV-Vis
• Fluorometers
• Plate Readers
• Cell Sorters, Cell Counters
• TOC Analyzers
• Dissolution Apparatus
• Calorimeters
• Densitometers
• Auto-titrators
• Gamma Counters
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| Learn how Cimquest's Q-Factors™
can help you create the necessary building blocks
to attain Hi-Q operational excellence.
Go
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 The
Global Compliance Alliance™ is a leading compliance
solution provider across America, Asia, and Europe.
Providing highly qualified Consultants through out the
world, the GCA gives you
the benefits of a global partner capable of dealing with
world wide multi-site projects.
Click
here to learn more about the Global
Compliance Alliance™. |
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Copyright©2003, CimQuest, All rights reserved
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Part
11 White Paper