Life Sciences

Amazon Web Services – Using AWS In GxP Systems January 2016 Page 3 of 34 Table of Contents 1 ABSTRACT .............................................................................................................................4 2 INTRODUCTION ..................................................................................................................5 2.1.1 About AWS ............................................................................................................. 5 2.1.2 AWS Customers ..................................................................................................... 6 2.1.3 AWS Technology .................................................................................................... 6 2.1.4 AWS Products ........................................................................................................ 8 3 USING AWS PRODUCTS IN GXP SYSTEMS ................................................................ 10 3.1 Quality Systems .................................................................................................... 10 3.1.1 Management Responsibility ............................................................................... 10 3.1.2 Personnel .............................................................................................................. 11 3.1.3 Audits .................................................................................................................... 11 3.1.4 Purchasing Controls ............................................................................................ 12 3.1.5 Product Assessment ............................................................................................ 14 3.1.6 Supplier Evaluation ............................................................................................. 15 3.1.7 Supplier Agreement ............................................................................................. 17 3.1.8 Records & Logs ..................................................................................................... 18 3.2 System Development Life Cycle ......................................................................... 19 3.2.1 Develop .................................................................................................................. 20 3.2.2 Validate ................................................................................................................. 22 3.2.3 Operate .................................................................................................................. 24 3.3 Regulatory Affairs ................................................................................................ 27 3.3.1 Submissions .......................................................................................................... 27 3.3.2 Inspections............................................................................................................ 28 3.3.3 Personal Data Privacy Controls for Research Participants ............................ 29 4 CONCLUSION .................................................................................................................... 29 5 DOCUMENT REVISIONS ................................................................................................. 30 6 APPENDICES ...................................................................................................................... 31 6.1 Data Privacy Resources ....................................................................................... 31 6.2 Annotated 21 CFR Part 11 .......................................................................................... 32 6.3 Shared Responsibilities in AWS Agreements ......................................................... 34

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