Transcription of Practical risk-based guide for managing data integrity
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Practical risk-based guide for managing data integrity
1. ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE. Practical risk- based guide for managing data integrity Version 1, March 2019. 2. PREAMBLE. This original version of this guidance document has been compiled by a subdivision of the APIC Data integrity Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC) of CEFIC. The Task Force members are: Charles Gibbons, AbbVie, Ireland Danny De Scheemaecker, Janssen Pharmaceutica NV. Rob De Proost, Janssen Pharmaceutica NV. Dieter Vanderlinden, Ajinomoto Omnichem Andr van der Biezen, Aspen Oss Sebastian Fuchs, Tereos Daniel Davies, Lonza AG.
Practical risk-based guide for managing data integrity Version 1, March 2019 . 2 ... processes and only at the end drilling down to individual activities or systems that involve GxP data. Figure 1 is a graphical representation of this approach and the sequence of steps that should help
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