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How Mature Is Your Data Integrity? New FDA and EU Regulatory Focus Areas
October 23, 2025Data integrity has been in regulators’ spotlight for decades, and the expectations for ensuring data integrity are evolv...
Are you ready for the FDA guidance on Data Integrity and Compliance?
September 23, 2024The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is...
23 Data Integrity FAQs Answered By The EMA
September 22, 2016Last month, the EMA’s Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group publ...
New from PIC/S: Draft Guidance on Data Integrity
September 10, 2016Earlier this year, the FDA published draft guidance on Data Integrity and Compliance for GMP. And now PIC/S has publishe...
Are you prepared for WHO draft guidance on Good Data and Record Management Practices?
October 05, 2015In September 2015, the World Health Organization (WHO) published a draft guidance document focused solely on data integr...