In this webinar you will learn how to maintain data integrity in environmental monitoring applications. Participants will get an up-to-date overview of the current regulatory expectations for practices that ensure 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 globalization and increasing use of digital information with computerized 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.
Watch this webinar 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, the recording includes a lively Q&A session at the end.
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
Who Should Watch:
- Regulatory Officers
- Quality Managers (QA/QC)
- Facilities & Operations
- Stability Scientists
- Warehouse & Distribution
- Laboratory Managers
- Project Managers
- R & D, Clinical Trials