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Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS U.S. Department of Health and Human Services Food and Drug Administration Center for Biologic Evaluation and Research (CBR) Center

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What is computerized systems used in?

Computerized systems are used in various industries and sectors, including healthcare, finance, manufacturing, transportation, and communication.

Who is required to file computerized systems used in?

The individuals or organizations that are responsible for operating and maintaining computerized systems are typically required to file information about these systems.

How to fill out computerized systems used in?

The process of filling out computerized systems used in may vary depending on the specific requirements and regulations set by the governing body. It generally involves providing detailed information about the system, its functionality, data storage and access controls, and any security measures implemented.

What is the purpose of computerized systems used in?

The purpose of computerized systems used in is to ensure the proper management, security, and control of electronic data and information. It helps to maintain the integrity and reliability of computer systems and protect against unauthorized access or use.

What information must be reported on computerized systems used in?

The specific information that must be reported on computerized systems used in can vary depending on the regulatory requirements. Generally, it includes details about the system architecture, data storage methods, access controls, backup and recovery procedures, and any security measures implemented.

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