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Computer System Validation
Valicom
is experienced with validation of computer systems, including information
systems, test equipment, laboratory instrumentation, automated
manufacturing systems, and medical devices.
Some of our areas of expertise include:
 | Validation
of Laboratory Information Management Systems (LIMS),
including design. |
We specialize in Applied
Biosystems’ SQL*LIMS product.
We’re familiar with the vendor’s validation
protocols, as well as validation of customizations, such as
reports, PL-SQL code, custom tables and forms, custom labels and
barcodes, and laboratory instrument interfaces.
We’re also well-versed in a
number of applications of SQL*LIMS, including uses for QC
testing, environmental monitoring, stability testing, and
clinical trial management.
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| Design
and validation of custom databases and spreadsheets,
including validation of embedded macros and Visual Basic
script.
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| Configuration
and validation of chromatography equipment
(HPLC, GC, and CE), including validation of networked data
systems (e.g. Agilent’s ChemStation/ChemStore and Waters’
Millennium).
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| Validation
of other laboratory and process testing instruments,
such as spectrophotometers and spectrometers, TOC analyzers,
tablet testers, and other types of automated in-process test
equipment.
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| Development
and maintenance of GAMP documentation,
including requirement specifications, functional
specifications, validation master plans, design documents, and
traceability matrices.
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| Preparation
of risk assessments.
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| Please
contact us for a quotation on these
services! Geographic and
industry keywords:
San Diego, North County, Carlsbad, Orange County, Los Angeles,
Ventura, Riverside, San Bernardino, biotech, pharmaceutical, pharma,
biologics, drug, medical device, API, supplier, GAMP, FDA, GMP, GLP,
GCP, GxP, cGMP |
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