Transcription of GOOD PRACTICES FOR DATA MANAGEMENT AND …
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GOOD PRACTICES FOR DATA MANAGEMENT AND …
PI 041-1 (Draft 3) 1 of 52 30 November 2018 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME 1 PI 041-1 (Draft 3) 2 30 November 2018 3 4 5 6 7 8 9 PIC/S GUIDANCE 10 11 12 13 14 GOOD PRACTICES FOR data MANAGEMENT AND integrity IN REGULATED GMP/GDP ENVIRONMENTS 15 16 17 18 19 20 21 PIC/S November 2018 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. 22 23 24 25 26 Editor: PIC/S Secretariat e-mail: web site: 27 28 PI 041-1 (Draft 3) 2 of 52 30 November 2018 TABLE OF CONTENTS 29 Page 30 31 1.
2.4 Data Integrity is defined as “the extent to which all data are complete, consistent and ... required for data verification and evidence of operational compliance with 169 procedures. 170 4.3 Whilst this document has been written with the above scope, many principles
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