News & Views
Webinar: Data Integrity in Pharmaceutical Environments - Beyond Bytes and Signatures
Oct 03 2018 Read 715 Times
You are invited to a live, complimentary online tutorial on data integrity in GxP environments. Join us on November 7th to 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. Plus, we’ll leave time for a question and answer session to be sure to address your application-related questions.
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
All systems that record information for GxP-regulated applications - be they manual, automatic or hybrid - have inherent data integrity risks. Data integrity is not a novel regulatory requirement, but compliance failures and enforcement actions are becoming more common as regulatory scrutiny increases. With globalisation and increasing use of digital information with computerised systems, several new regulatory guidance documents have recently been published to clarify how data should be recorded, processed, stored and retrieved. In this webinar, we review some recent publications.
However, 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.
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