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computer validation services on the following systems: |
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Control systems for sterile/biotech equipment/systems including lyophilizers,
sterile/bioreactors, filter systems, filter integrity test systems,
pressure/temperature controls, packaging systems and environmental controls.
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Laboratory systems including ovens, coolers, freezers environmental controls,
laboratory information systems (LIMS), chromatography data collection systems
and instrumentation. Other instruments validated include: UV-Vis spectrometers,
FT-IR spectrometers, high performance liquid chromatography (HPLCs), gas
chromatographs (GCs), and capillary electrophoresis systems (CEs). |
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Information management systems including
electronic documentation management systems, laboratory information management
systems (LIMS), maintenance management systems (MMS), manufacturing resources
planning system (MRP II, ERP), order management systems (OMS), supervisory,
control and data acquisition systems and (SCADA) systems and manufacturing
execution systems (MES).
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Bulk pharmaceutical manufacturing processing
trains including reactors, blenders, centrifuges, dryers, temperature controls,
vacuum/pressure controls, dispensing controls, and automated sequences.
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Programmable Logic Controllers (PLCs) utilized to
control pharmaceutical process equipment.
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Database management systems including, Oracle,
Sybase, MS SQL server, DB/2, and MS Access.
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Computerized Clinical Data Acquisition and
Management Systems.
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Solid dosage, ointments, creams, liquids and
sterile packaging lines including check weighers.
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PREMIER has delivered a variety of services to the pharmaceutical industry: |
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. Master Plan
. IQ/OQ/PQ Protocols
. Protocol Execution
. Factory Acceptance Tests
. Facilities and Equipment
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