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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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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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Computer Systems Validation
Experience - Representative
Systems |
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Enterprise Resource Planning
(ERP) Systems |
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Laboratory Information
Management System (LIMS) |
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Document Management Systems
(DMS) |
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Adverse Event Systems |
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Network Infrastructure
Qualification |
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Laboratory Systems |
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Spreadsheet Validation |
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Plant Floor Systems |
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Equipment/Systems Validation |
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Label Management Systems |
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Manufacturing Execution
Systems (MES) |
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Clinical Trial Management
Systems |
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Source Code Reviews |
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Change Management Systems |
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Batch/Process Data
Management System |
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Database Querying and
Information Retrieval in a
Controlled, Part 11
Environment |
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Computerized Maintenance
Management Systems |
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Engineering Drawing
Management System |
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Environmental Monitoring and
Trending |
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Training Systems |
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2000-2010. CIMCON Software, Inc. All rights reserved. |
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