The Computer System Validation Revolution

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There are two parts to this webinar: 1) Computer Systems Validation; and, 2) Data Integrity Compliance.


The world of “Computer System Validation” or CSV is changing. Now there is talk of “Computer Software Assurance” or CSA. This new way of thinking essentially emerged from FDA’s new “Case for Quality” (CfQ) initiative. During this webinar you’ll understand how Computer Software Assurance and Case for Quality can be leveraged to benefit your organization. Couple the new paradigms in thinking with new software programs that deliver paperless validation and automated testing and what you get is a holistic and comprehensive suite of technologies and methodologies that, when brought together, deliver capabilities and efficiencies that have not been achievable until now.


This webinar will not only provide insight on these topics but will also provide details on how this has actually been put to use with amazing results.


The second part of this webinar will discuss Data Integrity.  Beyond a conversation of ALCOA and ALCOA+, the presenter will discuss proper handling of Audit Trails. For example, how do you handle data privacy’s right to erasure if personally identifiable data is recorded in the audit trail. Another exciting topic is the hidden treasures buried within an audit trail. Did you know the audit trail can be a valuable resource for security related purposes and even a data pool that can be used by Artificial Intelligence and Machine Learning (AI/ML) algorithms? In fact, a Data Integrity audit can be performed by leveraging technology, including AI/ML, that may deliver more than what a human being can deliver. During this webinar you’ll see how this may be used in your own organization.


Top Ten Benefits

  1. Hear, first-hand, how one company bridged the divide between the Quality and Technical teams
  2. Understand how to create Risk matrices to eliminate subjectivity in risk-related processes
  3. Learn how to employ a “least burdensome approach” that is defendable by using data and process flows
  4. Gain reassurance that a good paperless solution can deliver more than legacy paper-based processes
  5. See how much money can actually be saved
  6. See how much more efficient Validation-related processes can become
  7. Understand how new prevailing technologies can be assessed and deployed, today
  8. Gain insight on how qualification and validation can be leveraged
  9. Learn how an audit trail can help improve computer security
  10. Get a glimpse into the near-term future on how Artificial Intelligence and Machine Learning (AI/ML) can directly benefit your company

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Steve Thompson

Director Computer Quality Assurance, Science 37, Inc.

Mr. Thompson over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that includes biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and received a Bachelor of Science, Computer Information Systems, in 1986.