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Computer System Validation
The critical nature of computer technology utilized in laboratory and manufacturing environments requires a thorough evaluation of computer systems and programs to verify compatibility with industry and regulatory expectations.

When implemented, a thorough computer validation program provides the necessary protocols, certifications, testing and implementation of all the necessary development phases into a comprehensive program.

VSI has experience including the validation of laboratory and manufacturing information systems, automated manufacturing lines and facility supervisory control and monitoring systems. VSI is available to provide the latest technical and regulatory consulting.

We offer complete services with the development of computer validation plans and gap analysis to work with in-place programs. Product development details are assessed within this program in accordance with a life-cycle approach. User requirements, system and functional specifications are developed and incorporated into the necessary test scripts. A traceability matrix is implemented to provide a complete approach to addressing all program requirements from conceptual design to final product. Supplier audits, assistance in procedural development or review for maintenance, operation, and configuration management of the system are also performed to complement the computer validation program.

   

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