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Valicom is pleased to offer the following
services:
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Computer System Validation
| Equipment Validation
Facility Validation | Cleaning Validation |
Part 11 Compliance
Procedure and Policy Development
| Auditing |
GxP Compliance
HIPAA Compliance | Training
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Computer
System Validation
 | Laboratory Information Management System
(LIMS) validation and design, |
| Custom database and spreadsheet development
and validation, |
| HPLC, GC, and CE equipment validation,
including configuration and validation of networked data
systems, |
| Preparation of validation master plans, |
| Development of requirement specifications,
design documentation, traceability matrices,and other GAMP
documentation, |
| ...and more. |
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Manufacturing
Equipment Validation
| Process control system configuration and
validation, |
| Automated manufacturing equipment validation, |
| Test equipment configuration and validation. |
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21
CFR Part 11 Compliance
| Compliance assessment of laboratory,
manufacturing, and support systems, with consideration given
to FDA's 2003 Scope and Application document, |
| Configuration, remediation, and validation of
deficient systems. |
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Procedure
and Policy Development
| Preparation, review, and revision of
corporate quality policies and validation policies, |
| Preparation of procedures for the operation
and administration of computerized systems, |
| Development of change control policies and
procedures, |
| Development of SOPs for operation of
laboratory equipment and manufacturing equipment. |
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Auditing
and related GxP compliance services |
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Please
contact us for a quotation on these
services! |
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this page: San Diego, Los Angeles, Orange County, Ventura,
Riverside, San Bernardino |
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