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VALIDATION SUPPORT SERVICES
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The
overall goal of HiTech's validation service is to efficiently assist
the customer in affirming that all regulatory requirements are
established, systematically implemented, and properly functioning.
HiTech has the experienced professional resources with the abilities,
attitudes and reputation, to provide you with high performance service
at a very competitive value. We provide unique value, because our
validation personnel also have extensive years of experience with
automation control and high volume mechanical processes. HiTech's
engineers have an intimate understanding of cGMP's and we clearly
understand the validation needs and current validation methodologies.
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AREAS
OF EXPERTISE
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SAMPLE
OF SERVICES OFFERED
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Development
of Validation Master Plan, Scope and Schedule |
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Project
Management and Cost Engineering |
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Equipment
Engineering, Plant Layout, Procurement, Design, Fabrication,
Construction and Start-up |
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Prospective
Validations (experimental test) to establish Baseline Standards and
Benchmark Criteria |
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Retrospective
Validations to affirm qualifications of Batch Recipe Process, |
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Line
Equipment, Control Systems and Work Systems |
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Procedural
Instructions for Operating, Calibration, Maintenance and Change Control |
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Formal
Technology Transfer & Training of Operators and Technicians |
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Systems
Improvements for added functionality, increased reliability, efficiency
and throughput |
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Validation
Final Report and Project Closure and Follow-up |
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