34th SQA Annual Meeting and Quality College

H-1  The Role of Metadata and Audit Trails in Ensuring Data Integrity 

Abstract:
Audit trails and other metadata are rightfully given significant attention in regards to their ability to explain data and support its integrity. These records are generated by computerized systems and tell the story about how the data was collected and used. However, systems used in GxP regulated activities generate audit trails that span the spectrum in regards to their content, organization, and usefulness. They can range from meeting the bare minimum of regulatory requirements (or maybe less) to recording nearly every keystroke.  This session will explore the role of metadata in the data lifecycle and how it can be used to evaluate data for integrity. In addition, approaches towards reviewing metadata and audit trails will be discussed in order to more efficiently and effectively use these records.

Category:
IT Compliance

Level of Content:
Intermediate

H-2   SEND – from zero to a converted (outsourced) study – a case study 

Abstract:
The requirements to submit non-clinical data using the SEND standard are here and in force.
Guidance for business process implementation has been scarce and we’ve all been learning as we go.
This presentation explains the process that was followed by one company to be in a position to confidently provide a SEND converted study to a sponsor in a timely fashion.
We will walk through the process from the rationale to outsource, supplier selection, pilot tests through to a completed study and all the steps in-between.

Category:
IT Compliance

Level of Content:
Intermediate

H-3  What you need to know about GDPR! 

Abstract:
The EU GDPR will go into effect in May 2018 and will require businesses to focus on identifying and protecting sensitive personal data of EU Citizens. In this session, we will share practical insights for what, as a quality assurance professional, need to know about the regulation and what to look at during an audit to improve data governance, reduce the risk of data loss and ensure compliance.
We will discuss the following Points as they relate to the EU data protection regulation:
-The role of data classification in protecting critical data assets.
-Data security.
-Transfer of data outside the EU.
-Pseudonymizing / anonymization.
-Joint Controllers
-Data Protection Officer (DPO)

Category:
IT Compliance

Level of Content:
Basic