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 IntegrityAttributable, 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