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GMP Certification Program
Certified Computer Validation ManagerSpeakersFrank Bench
CSL BehringComputerised System Validation
Introduction to Risk Management
The GAME 5 Approach
23 April 2024 and
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How to fill out computer validation- introduction to
How to fill out computer validation- introduction to
01
Start by understanding the purpose of computer validation- introduction.
02
Gather all necessary information and documentation related to the computer system being validated.
03
Review and understand the validation requirements specified by regulatory agencies or internal guidelines.
04
Create a validation plan outlining the approach, scope, and timeline for the computer validation process.
05
Execute the validation plan by testing the system functionality, documenting test results, and identifying any issues or deviations.
06
Review and approve the validation documentation before finalizing and closing the validation process.
Who needs computer validation- introduction to?
01
Individuals or organizations involved in the design, development, implementation, or maintenance of computer systems used in regulated industries such as pharmaceuticals, medical devices, or food and beverage manufacturing.
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What is computer validation- introduction to?
Computer validation is the process of ensuring that computer systems and software used in regulated environments meet specified requirements for quality, safety, and efficacy.
Who is required to file computer validation- introduction to?
Organizations involved in the development, manufacturing, and distribution of products regulated by government agencies, such as pharmaceuticals and medical devices, are required to file for computer validation.
How to fill out computer validation- introduction to?
To fill out computer validation, organizations must document the system's intended use, perform risk assessments, conduct testing, and provide evidence of compliance with regulatory standards.
What is the purpose of computer validation- introduction to?
The purpose of computer validation is to ensure that computer systems reliably produce accurate and consistent results, thereby maintaining product quality and compliance with regulatory requirements.
What information must be reported on computer validation- introduction to?
Information that must be reported includes system specifications, validation protocols, test results, any deviations, and corrective actions taken.
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