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Data Integrity and Compliance With CGMP Guidance for Industry
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Tina Morris, PDA, Maik Jornitz, G-Con, Gabriele Gori, GSK, and Hal Baseman, ValSource, PUPSIT and the Annex 1 Revision, PDA Letter, Aug 29, 2019
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PIC/S GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS