Biometrix has extensive experience in the development and execution of high quality software validation protocols. Biometrix can provide and execute software validation protocols such as Installation, Operational and Performance Qualification. Biometrix can also develop software specification documents such as Design, Functional and User Requirement Specifications.

Biometrix can provide expert software and computer related systems validation consulting services for a variety of systems, including:

• Calibration management
• Laboratory monitoring
• Quality management
• Document control
• Pipette calibration
• Clinical trials management
• Capital equipment management
• PLC-based systems
• Microprocessor-based systems
• Software-based control systems, including DeltaV

Biometrix provides a comprehensive validation report package that includes a summary of all test results including deviations, the executed protocol, test data, test equipment calibration data with NIST-traceable calibration certificates. The validation report package is carefully prepared, reviewed and submitted for client approval.

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