Although the concept of Data Integrity (DI) is not new, there are uncertainties in the pharmaceutical industry as to how to implement these requirements into daily business, and more specifically, integrating data governance into GxP Quality Systems.
Inspection results commonly show inadequate controls on the integrity, authenticity, and reliability of data, therefore embedding DI across the company culture is becoming essential.
This course is designed to provide guidance on regulatory requirements, DI risk-based approach, concepts and components ensuring Data Integrity across its lifecycle, from initial generation, recording, through processing, use, retention, archiving and retrieval.
Understanding Data Integrity is the basis for implementing systems and processes that fulfil the expectations of the health authorities.
Several guidance documents have been published within the last few years detailing Health Authorities’ expectations on implementing data governance, establishing control measures, and how procedures should cover the lifecycle of data and documents.The first day will cover these regulatory requirements and Data Integrity expectations for data and documents, related key concepts, and expands on the practicalities of assessing Data Integrity Risks and Compliance Controls.
The second day is built as a workshop focusing on real-life examples. Split into small groups we will analyse real cases, investigate the root cause, define priorities, and end with potential corrective and preventive actions. Results are shared and discussed with all participants during the day. This workshop will lead course participants to be able to develop activities that will help achieve DI compliance in their own business and to better understand the importance of DI across the GxPs. Attendees will gain best practices to ensure their data is managed reliably and to be able to minimize the threats of poor Data Integrity to clinical trials.
The course provides a mixture of presentations, discussions and practical workshops.