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GMP Certification Program Certified Computer Validation ManagerSpeakersComputerised System Validation:GMP Compliant Documentation Dr Bernhard Appeal Roche DiagnosticsLive Online Training from 1113
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How to fill out computerised system validation

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How to fill out computerised system validation

01
Define the validation strategy and requirements.
02
Identify and document the system features and functions to be validated.
03
Develop validation protocols and test scripts.
04
Execute validation protocols and document results.
05
Review and approve validation documentation.
06
Maintain validation documentation and conduct periodic reviews.

Who needs computerised system validation?

01
Companies in industries regulated by government agencies such as pharmaceutical, medical device, and biotechnology companies.
02
Organizations that use computer systems for critical functions that impact product quality, safety, or data integrity.
03
Companies that need to comply with regulatory standards like FDA 21 CFR Part 11.
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Computerised system validation is the process of ensuring that a computer system meets the requirements set forth by regulatory agencies and operates in a reliable and secure manner.
Companies in regulated industries, such as pharmaceutical, medical device, and food manufacturing, are required to file computerised system validation.
To fill out computerised system validation, companies must document and test their computer systems to ensure they meet regulatory requirements.
The purpose of computerised system validation is to ensure that computer systems used in regulated industries operate accurately and reliably to maintain data integrity and patient safety.
Information reported on computerised system validation includes documentation of system requirements, testing protocols, and validation results.
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