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Validation and Compliance Consulting Services |
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Planning |
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Master Validation Plan (MVP) |
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Risk Assessment |
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Requirements |
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User Requirements
Specification (URS) |
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Design |
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Software Design
Specification (SDS) |
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Hardware Design
Specification (HDS) |
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Configuration |
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Hardware Configuration
Specification (HCS) |
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Application Configuration
Specification (ACS) |
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Specifications |
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Functional Specifications
(FS) |
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Standard Operating
Procedures (SOPs) |
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Testing |
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Installation Qualification
(IQ) |
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Operational Qualification (OQ) |
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Performance Qualification
(PQ) |
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Reporting |
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Summary Reports |
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21 CFR Part 11 Services |
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Strategy and Planning |
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System Inventory |
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Gap Analysis |
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Remediation |
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Technical Controls |
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Procedural Controls |
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© Copyright
2000-2008. CIMCON Software, Inc. All rights reserved. |
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