Electronic Data Integrity – Free Webinar

Register for an Upcoming Session

Since 2015, the FDA, MHRA, WHO and other agencies have been publishing Data Integrity guidelines to increase the industry’s understanding of the expectations for compliance. Many of these guidelines are heavily focused on the integrity of electronic data and records.

In this session, you will learn how regulators have become increasingly prescriptive in their requirements, and how the well-understood requirements for paper data integrity are translated to apply to electronic records and computer systems. Then we will define many of the key terms and concepts necessary to grasp the intentions of the regulators’ guidelines on data integrity.

This webinar will describe actions that your organization can take now to prevent or remediate electronic data integrity gaps in the following 10 critical areas:

  1. Security and user access
  2. Audit trails
  3. Back-ups
  4. Record storage
  5. Record copies
  6. Validation
  7. Issue investigation
  8. Out-sourced services
  9. Out-sourced systems
  10. Training

And, since much can be learned from FDA Warning Letters, we will look at examples of both common and surprising data-integrity compromising practices that have been cited in the last few years.

We will conclude the webinar with scenarios from recent audits to provide examples of where to look for risks to electronic data integrity in your organization.

Electronic Data Integrity Webinar Topics:

  • History and evolution of Data Integrity regulations and guidelines
  • Essential terminology for understanding the recent Data Integrity guidelines
  • 10 principal themes for electronic Data Integrity compliance
  • Awareness of FDA expectations through review of Warning Letters for electronic Data Integrity compliance violations
  • Examples of where to look for electronic Data Integrity risks in your organization.


Cost: FREE

We are offering this webinar on the following dates: