Data Integrity 

Agenda                                                                                                                              
Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity also refers to the safety of data in regard to regulatory compliance — such as GDPR compliance — and security. It is maintained by a collection of processes, rules, and standards implemented during the design phase. When the integrity of data is secure, the information stored in a database will remain complete, accurate, and reliable no matter how long it’s stored or how often it’s accessed.

Module 1   What is Data Integrity

Module 2   Current Legislative Requiements

Module 3  Current Challenges facing Regulatory Agencies

Module 4  Regulatory Agencies Inspection Focus

Module 5  DI Strategies

Module 6  The way forward

Learning Outcomes

The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned by Regulatory agencies which are  noticing a significant increase in data integrity issues. 

Regulatory concerns and warning letters have extended to all areas of the medical device and pharmaceutical businesses including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.