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| | If
you do not know and understand the quality of data, services or products you are
using, you may be jeopardizing your reputation, financial security or safety.
These items may be generated within your own
organization, by an outside contractor, or by a public body.
For
example, how
accurate, reliable, reproducible, and defensible is that data? Can you trust it implicitly?
The
questions that you should be asking the data generator include:
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How
was the data generated?
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Was
the analytical system in control?
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Are
records available?
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Has
the method used been validated?
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At LCV Company, we know what questions to ask
and how to interpret the answers. Some of the services we offer are:
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Adequacy assessment of your/their quality
assurance systems (are all necessary systems in place? are the systems
consistently implemented?) |
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Verification of method validation and proficiency
sample results (can the laboratory do what they say they can do?) |
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Assessment of supporting documentation and
records (were the required records generated? are they available? do they
provide traceability? are Chain-of-Custody records complete?) |
| On-site audit of facilities to provide you
with an overall picture of quality, or audit of specific
process/operation/products you are concerned with |
| Create or revise quality systems for your
organization |
| Perform readiness assessments prior to regulatory
audits |
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Creation of Standard Operating Procedures |
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