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Validation and 21 CFR Part 11 Compliance
Services |
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CSI's independent Consulting Services group has extensive experience in providing Validation and 21 CFR Part 11 Compliance services following GAMP 4 methodology that includes the following:
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Computer-Related Systems |
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Spreadsheet Validation |
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Enterprise Systems
(ERP, MRP-II) |
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Plant Floor Systems
(MES, SCADA, DCS) |
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Laboratory Systems
(LIMS, Stability) |
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Electronic Document Management Systems
(EDMS) |
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Computerized Maintenance Management Systems (CMMS) |
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Database Management (Environmental Monitoring, Trending) |
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Validation and Technical Services |
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Validation Planning (Validation Plans and Procedures) |
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Preparation of Functional and Design Specifications |
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IQ, OQ and PQ Protocol Preparation and Execution |
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21 CFR Part 11 Assessments and Remediation |
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Data Migration and System Configuration
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GAMP 4 Based Validation Package |
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A comprehensive and detailed validation package
based on GAMP 4 methodology
is available
to accelerate system implementation
and reduce costs. |
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© Copyright
2000-2010. CIMCON Software, Inc. All rights reserved. |
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