
EMA Releases Data Integrity Guidance
The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.
On August 11, 2016, the European Medicines Agency (EMA) announced the publication of a new GMP
The EMA guidance includes a set of questions and answers developed by the agency’s GMP/Good Distribution Practice Inspectors Working Group. The document addresses the assessment of risk to data integrity, risk-management strategies, design and control of electronic and paper-based documentation systems, and ensuring data integrity of outside contractors.
EMA stated in a
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