23 Data Integrity FAQs Answered By The EMA
By Deb Bartel,
This post was recently updated on September 19, 2018
Last month, the EMA’s Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group published their answers to 23 frequently asked questions related to Data Integrity and the Data Life Cycle.
EMA’s Recommendations
This Q&A document provides insight in the EU regulators’ expectations regarding data risk assessment and mitigation; data security, protection, and retention; electronic signatures; electronic data review; and, ensuring that data integrity standards are met by suppliers and service providers.
Download the entire Q&A session here: EMA Data Integrity for GMP and GDP Q&A
Do you need more help understanding how these topics might affect your organization? Talk to our CSV experts about how you can ensure your processes meet the EMA’s standards.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
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