Software-driven data collection systems are now ubiquitous in preclinical, clinical, and manufacturing settings in the life sciences. The data collected, processed, and maintained by these systems are used by regulatory agencies to make decisions regarding approvals. Therefore, this data – and the systems used to collect it – must meet regulatory requirements when submitted for review to an approving agency. Electronic data has many advantages over paper but it also creates new challenges in assuring accuracy and reliability. Because of these risks, the number of FDA Form 483 observations related to electronic data integrity is on the rise.
This training will underline the meaning of electronic data integrity and how to comply throughout the data lifecycle (i.e., creation to use to archive to deletion). By attending, participants will be able to orchestrate data governance and computer systems validation strategies that position organizations for compliance.
- Understanding data integrity and the data lifecycle within a GxP environment
- Applying current regulations and industry standards to electronic data
- Identifying the most common issues observed with electronic data integrity compliance, including example warning letters
- Understanding the role of robust data governance in achieving compliance
- Developing software validation strategies that increase data integrity compliance