Validating corporate computer systems

Posted by / 30-Dec-2020 15:25

Validating corporate computer systems

She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

The paper defines risk-based computer systems validation as not only a regulatory requirement, but also a practice that makes good business sense.

This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.

It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

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This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.

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risk, as it applies to the use of ER/ES capability Understand how to effectively document the process of computer system validation where ER/ES capability exists, and maintain current information about the various systems in your organization and how they are maintained in a validated state Learn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emerge Understand some of the key “pitfalls” to avoid when employing ER/ES capability Interactive Q&A Session Who Will Benefit: This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.

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