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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. Document history .. 3 32 2. Introduction .. 3 33 3. Purpose .. 4 34 4. Scope .. 5 35 5. data governance system .. 5 36 What is data governance? .. 5 37 data governance systems .. 5 38 Risk MANAGEMENT approach to data 6 39 data criticality .. 7 40 data risk.

context of good data management such as, data included in the registration dossier 110 based on which API and drug produc t control strategies and specifications are set. 111 2.4 Data Integrity is defined as “the extent to which all data are complete, consistent and 112 accurate, throughout the data lifecycle” 1

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