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Computer Validation:
Maintaining Control of
OperationIncluding new
requirements on
Data IntegritySPEAKERS:Frank Bench
CSL Behring Gyves Samson
Partner Robert Stephenson
Rob Stephenson ConsultancyKeep
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How to fill out computer validation - maintaining
How to fill out computer validation - maintaining
01
Understand the purpose of computer validation - maintaining.
02
Identify the systems and software that need to be validated.
03
Develop a validation plan outlining the process and timeline for validation.
04
Collect and review documentation and evidence supporting the validation process.
05
Perform testing and analysis to ensure the systems meet validation requirements.
06
Document all findings, actions taken, and results of the validation process.
07
Obtain approval from relevant stakeholders before closing out the validation process.
Who needs computer validation - maintaining?
01
Companies in regulated industries such as pharmaceutical, biotechnology, medical device, and food manufacturing.
02
Organizations that rely on computer systems to store, process, or analyze critical data.
03
Businesses that need to comply with regulatory standards such as FDA guidelines or GMP requirements.
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What is computer validation - maintaining?
Computer validation - maintaining is the process of verifying that a computer system meets the requirements and specifications it was designed for.
Who is required to file computer validation - maintaining?
Any organization or individual who uses a computer system that requires validation is required to file computer validation - maintaining.
How to fill out computer validation - maintaining?
To fill out computer validation - maintaining, one must provide detailed information about the computer system and its validation process.
What is the purpose of computer validation - maintaining?
The purpose of computer validation - maintaining is to ensure that a computer system operates correctly and reliably.
What information must be reported on computer validation - maintaining?
Information such as system specifications, validation methods, and validation results must be reported on computer validation - maintaining.
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