Data Integrity in Pharmaceutical Environmental Monitoring - Beyond Bytes and Signatures

Data Integrity for Life Science Environments
Industrial Measurements
Life Science

Maintaining good data integrity is about more than compliance with regulations. In life science applications, data often represents a significant investment in research, development, samples or donated tissue. In life science, data can also represent the hope of patients for a novel therapy or drug. As in all other aspects of regulated industry applications, these processes require  trustworthy systems to ensure patient safety.

In this webinar you will learn how to maintain data integrity in software used in GxP-regulated operations. Along with best practices for managing environmental data, we provide an up-to-date overview of the current regulatory expectations for practices that ensure data integrity. Webinar includes a question and answer period where are regulatory expert answered questions on data management in GxP-compliant operations.

Webinar Slides (includes links to further reading)

Key Learning Objectives:

  • Review of recent guidance and documents
  • Learn how to evaluate data integrity risks
  • Discuss common pitfalls of data management in GxP applications
  • Review best practices for ensuring and preserving data integrity

 

 

What customers say about viewLinc's data integrity

“After installing viewLinc we were pleased... but it was during the hurricane that it really proved itself. Once we were able to return to work, we began analyzing conditions during the power outage. ...We verified and saved product that might otherwise have been needlessly destroyed because of the storm. As a result, our products reached patients without interruption, and the savings were huge.”

Luis Johnson, Site Automation Engineer, Teva Pharmaceutical Industries

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Speaker

Paul Daniel

Paul Daniel

Senior Regulatory Compliance Expert

Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems.

At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.

Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.