Data Integrity

This course is aimed at new starters and existing staff as part of their ongoing Data Integrity training. This course provides a practical overview of the challenges and potential areas of non-compliance inherit within paper-based, electronic and hybrid systems. Trainees who complete the course will have an understanding of how well-managed data plays a pivotal role in their day-to-day work and also how to operate within regulatory expectations. It is a critical aspect of any GxP regulated environment, as such it is a crucial part of all regulatory inspections. It is vital that all personnel within organisations operating in such an environment, not only understand but have the requisite processes and systems in place to ensure regulatory compliance. The course covers it's importance, the requirements necessary and gives a clear breakdown of it's elements in order to meet regulatory expectation such as the MHRA and the FDA.

Aims of Data Integrity Course

• Increase understanding of Data Integrity
• It's impact on day-to-day activities
• Regulatory compliance

1. What is Data Integrity?
2. Why is it important?
3. The ALCOA principle
   1. Paper based, computer based and hybrid systems
4. Application of the ALCOA principles
5. Importance of Meta-Data
   1. Meta-Data and computer systems
6. Storage of Records
7. Importance of a positive quality culture
8. Assessment

The European GDP Guidelines (Euro GDP 2013/C 343/01) are also available online to read here.

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