Computer System Validation – The Big Picture

It’s not uncommon to find an organization that believes it can focus on just the vendor-supplied IQ/OQ documentation and that little else is needed to build a defendable computer system validation package. But a fundamental purpose of validating a computer system is to provide documented evidence that a system is fit for your intended use. What process will you follow to provide the required evidence? How will you document your intended use of the system? How will you ensure that your system has been sufficiently tested? Let’s take a step back and get a better look at the big picture.

To properly conduct a computer system validation, there are several questions to address well before executing any test scripts, as well as a few questions to address after that. Not to mention understanding the resources and expertise that are needed to make it happen.

In this one-hour webinar, we will review deliverables and activities critical to building and defending a best-practice validation process.  We will discuss the success factors that you should be incorporating today to help satisfy any FDA audit.  Lastly, we will explore what it takes to ensure validation success.  So, join us for an hour and get the big picture when it comes to computer system validation.

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Key Takeaways:

  • Discover the top 5 validation success factors you should be aware of
  • See how having the right team and resources ensures validation success
  • Learn the importance of performing risk assessments
  • Obtain a best-practice, recommended validation deliverable checklist

Who Should Attend:

  • Quality Assurance and Software Validation Engineers
  • Laboratory Directors, Managers, and Analysis
  • IT Management and Leaders

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Take-home ideas and checklists to ensure that your CSV project is a success.

This is a complimentary hour-long presentation including a Q & A section.