Data Integrity

About the Course

This eLearning module on Data Integrity provides a thorough understanding of the principles and practices essential for ensuring reliable and compliant data in pharmaceutical operations. It covers the types of data and records, introduces ALCOA+ principles, and emphasizes the importance of data being attributable, legible, contemporaneous, original, and accurate. The module also reviews key regulatory expectations, guidance documents, and real-world enforcement actions. Learners will gain insights into audit focus areas, common causes of data manipulation, and best practices for managing data integrity across both paper-based and electronic systems.

Content

• Data & Data Integrity
  • Understanding Data: Documents, Records, and Data
  • Integrity and Data Integrity
  • Data and record types
  • Principles of Data Integrity
  • Attributable, Legible, Contemporaneous, Original and Accurate Data
  • Data attributes and ALCOA+
• Regulations and Regulatory Actions
  • Regulatory expectations
  • Key Guidance on Data Integrity
  • IPA Data Integrity Guide
  • Regulatory Actions related to Data Integrity
• Audit Focus Areas to check DI
  • Auditing for data reliability
  • Reasons for data manipulation
  • Case study: DI risks and solutions
  • Data integrity in electronic systems and case studies
  • Meeting regulatory expectations
  • Data Integrity Management
  • Procedures and Policies for Data Reliability

Summary and Conclusion: Importance of data integrity and reliability in drug manufacturing

Final Evaluation: 3 attempts to achieve the passing score in the evaluation