Transcription of PHARMACEUTICAL INSPECTION CONVENTION …
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PHARMACEUTICAL INSPECTION CONVENTION …
PI 041-1 (Draft 2) 1 of 41 10 August 2016 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 041-1 (Draft 2) 10 August 2016 DRAFT PIC/S GUIDANCE GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS PIC/S August 2016 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. Editor: PIC/S Secretariat e-mail: web site: PI 041-1 (Draft 2) 2 of 41 10 August 2016 TABLE OF CONTENTS Page 1. Document history .. 3 2. Introduction .. 3 3. Purpose .. 4 4. Scope .. 5 5. Data governance system .. 5 What is data governance .. 5 Data governance systems .. 5 Risk management approach to data 6 Data criticality .. 6 Data risk .. 7 Data governance system review .. 7 6. Organisational influences on successful data integrity management.
PI 041-1 (Draft 2) 4 of 41 10 August 2016 2.4 Data Integrity is defined as “the extent to which all data are complete, consistent and accurate, throughout the data lifecycle”1 and is fundamental in a pharmaceutical quality system which ensures that medicines are of the required
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