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GMP Certification Program Certified Computer Validation ManagerSpeakersFrank Bench CSL BehringComputerised System Validation Introduction to Risk Management The GAME 5 Approach 6 May 2025 and 79 May

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How to fill out computer system validation and

01

Identify the computer system to be validated.

02

Develop a validation plan outlining the scope, objectives, and approach for validation.

03

Perform risk assessment to determine the criticality of the system and potential impact on data integrity.

04

Execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

05

Document all validation activities and results in a comprehensive validation report.

06

Review and approve the validation report before implementation.

Who needs computer system validation and?

01

Pharmaceutical companies

02

Medical device manufacturers

03

Biotechnology companies

04

Food and beverage manufacturers

05

Any organization that relies on computer systems to generate, analyze, or store critical data.

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What is computer system validation?

Computer system validation is the process of ensuring that a computer system meets the requirements of its intended use.

Who is required to file computer system validation?

Companies in regulated industries such as pharmaceutical, biotechnology, medical device, and food industries are required to file computer system validation.

How to fill out computer system validation?

To fill out computer system validation, companies must follow regulatory guidelines and document the validation process thoroughly.

What is the purpose of computer system validation?

The purpose of computer system validation is to ensure that computer systems are reliable, secure, and perform as intended.

What information must be reported on computer system validation?

Information such as system requirements, validation protocols, test results, and validation reports must be reported on computer system validation.

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