EMA Data Integrity for GMP and GDP Q&A, 8/16

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In August, 2016, the EMA’s Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group, published their answers to 23 questions related to Data Integrity and the Data Lifecycle.

Topics include

• data risk assessment and mitigation
• data lifecycle stages
• data security, protection, and retention
• electronic signatures
• electronic data review
• ensuring data integrity in suppliers and service providers