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Including 9 interactive Workshops Computer Validation: Maintaining Control of Operation Keep your regulated systems in compliance throughout their operational life! 24 26 September 2014, Prague, Czech
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What is computer validation maintaining control?
Computer validation maintaining control is the process of ensuring that computer systems used in various industries are functioning correctly and reliably, while maintaining control over data integrity, security, and compliance with regulatory requirements.
Who is required to file computer validation maintaining control?
The entities or organizations that are using computer systems in regulated industries such as pharmaceutical, biotechnology, medical device, and other sectors are required to file computer validation maintaining control.
How to fill out computer validation maintaining control?
Filling out computer validation maintaining control involves following industry best practices and regulatory guidelines, which typically include documenting system requirements, conducting risk assessments, performing validation testing, and maintaining comprehensive documentation throughout the system's lifecycle.
What is the purpose of computer validation maintaining control?
The purpose of computer validation maintaining control is to ensure that computer systems used in regulated industries operate reliably, accurately, and securely, while meeting regulatory compliance requirements. It helps to minimize the risks associated with using computer systems in industries where the integrity of data and regulatory compliance are critical.
What information must be reported on computer validation maintaining control?
The specific information to be reported on computer validation maintaining control may vary depending on industry, regulatory requirements, and internal policies. However, it generally includes system documentation, validation plans and protocols, test results, change control records, and other relevant documentation that demonstrate the compliance and control over computer systems.
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