Data integrity translates into the consistency, completeness, and accuracy of data. It is required in all aspects of biopharmaceutical development and manufacturing, including emerging technologies like block chain, as you introduce them into your Quality Management Systems. Consistency, standardization, and traceability are some of the many issues we face when it comes to data integrity. Once we have specific foundational procedures and policies in place, we can control behavior as well as procedural and technical gaps of data integrity. It is essential to build these measures into everything we do, every day. If your organization loses its data integrity, it can never be regained!
We invite you to view Tanya Sharma, Co-Founder of Assurea LLC as she joins Qualio and SMHart Systems to discuss the critical nature of standardizing data integrity in all facets of biopharmaceutical activities. In this webinar, Tanya shares findings from ISPE’s Data Integrity by Design guidance document, which highlights how unifying system and risk elements throughout an entire organization, as well as the need for critical thinking and full understanding of risk, inputs and outputs of data being created and transferred, are basic requirements to achieve data integrity. You will learn, among other things, the importance of eliminating barriers and silos in documentation and leveraging quality management systems, maintaining data lifecycles, and having periodic review and change control procedures in place.
This webinar is intended for anyone – whether in start-ups or large, established organizations, engaged in quality management, regulatory compliance, or QMS documentation. It offers step-by-step approaches to understanding critical information on qualifying systems, standardizing document workflow, and maintaining consistency for the qualification process. Based on FDA findings, 41%-48% of errors happen due to the lack of consistent data and quality management. Watch this to learn more about how to protect your organization and ultimately ensure safety for patients in your drug development initiatives.