Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements. This eLearning course is aimed at anyone working in the Pharmaceutical Industry and provides an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle.
The key learning objectives are to provide an understanding of:
- Key data integrity terms and definitions
- Good documentation practice in relation to data integrity
- Good documentation design to allow good documentation completion and the five main types of errors within records
- Review and approval of documents, including making corrections
- Audit trail review
- Document right first time metrics
By completing/passing this course, you will attain the certificate Medical Device Certificate
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