Data integrity - Q & A from EMA

The european medicines agency has published 23 questions and aswers regarding Data integrity.
They describe foundational principles which facilitate successful implementation of existing guidance published by regulatory authorities participating in the PIC/S scheme.

Link in Gate2GMP® (need to be logged in): http://gate2gmp.com/system/files/ema_qna_dataintegrity_1608.pdf

Link at EMA: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000027.jsp&mid=WC0b01ac05800296ca#section17

 

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