Implementation of a validated system typically adds
25% to 50% to total system cost. Life sciences companies must develop
cost-effective strategies and relationships with experienced validation
partners to achieve efficiencies that will mitigate cost.
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Compliance focused GAP analysis
and recommendations |
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Technology assessment and evaluation |
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Implementation of custom and commercial
of the shelf (COTS) IT systems |
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Infrastructure qualification (networks,
servers, computer room environments) |
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Creation of computer system validation
policies and procedures |
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Management consulting services that establish
a risk-based approach to validation |
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Development of standard templates for validation
documents |
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IQ/OQ/PQ planning, development, and execution |
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Delivery of validation life-cycle training tailored
to client corporate polices |
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IT assessments that focus on the complete IT
integration |