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GMP Certification Program
Certified Computer Validation ManagerSpeakersFrank Bench
CSL Behring GmbHComputer Validation:Maintaining Control of
Operation
30 Sept 2 Oct 2020 | Copenhagen, Denmark Yves
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How to fill out computerised system validation master
How to fill out computerised system validation master
01
Identify the critical systems that need to be validated.
02
Develop a validation master plan outlining the scope, objectives, and activities of the validation process.
03
Perform risk assessments to determine the level of validation required for each system.
04
Generate validation protocols and test scripts for executing validation tests.
05
Execute the validation tests according to the protocols and document the results.
06
Review and approve the validation documentation to ensure compliance with regulatory requirements.
Who needs computerised system validation master?
01
Companies in industries that are regulated by agencies such as the FDA, EMA, or other regulatory bodies.
02
Companies that use computerized systems for critical processes that impact product quality, safety, and data integrity.
03
Companies that need to demonstrate compliance with regulatory requirements for validation of computerized systems.
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What is computerised system validation master?
Computerised system validation master is a document that outlines the validation procedures for computerized systems to ensure they meet regulatory requirements.
Who is required to file computerised system validation master?
Companies in industries that use computerized systems, such as pharmaceutical, medical device, and food manufacturing companies, are required to file computerised system validation master.
How to fill out computerised system validation master?
Computerised system validation master is typically filled out by validation experts or consultants who have experience in validating computerized systems.
What is the purpose of computerised system validation master?
The purpose of computerised system validation master is to ensure that computerized systems are validated to meet regulatory requirements and perform their intended functions accurately and reliably.
What information must be reported on computerised system validation master?
The information reported on computerised system validation master typically includes details about the system being validated, validation procedures used, test results, and any deviations or issues encountered during validation.
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