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2-day In-person Seminar: COMPUTER SYSTEM VALIDATION REDUCE COSTS AND AVOID 483S By: David Nettle ton, FDA Compliance Specialist, Computer System Validation Location 1: March 27-28, 2014 San Diego,

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What is computer system validation?

Computer system validation is the process of ensuring that a computer system meets certain predefined requirements and performs its intended functions correctly and consistently.

Who is required to file computer system validation?

The individuals or organizations that are responsible for the development, implementation, or maintenance of computer systems are required to file computer system validation.

How to fill out computer system validation?

To fill out computer system validation, you need to gather relevant information about the computer system, its requirements, and its intended functions. Then, you can follow established validation protocols and document the validation process.

What is the purpose of computer system validation?

The purpose of computer system validation is to ensure that computer systems used in regulated industries perform reliably, consistently, and accurately. It is done to minimize risks associated with errors or failures in these systems.

What information must be reported on computer system validation?

The information that must be reported on computer system validation includes documentation of validation protocols, test results, and any deviations from the predefined requirements. It may also include details about the system's architecture, software, and hardware components.

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