21 CFR Part 11 & Pharmaceutical Best Practices with Ignition

밸리데이션을 위한 가이드라인이며,

Qualification vs. Validation,

사이버 보완과 자원

클라우드 Part 11 자원 등의 유용한 자료를 포함하고 있습니다.

 

Table of Contents

Introduction 5

  Getting Started 5

  Background 5

    Ignition by Inductive Automation 5

    What is 21 CFR 11? 5

    About This Guide 5

      Convention 6

    Industry Direction 6

      CDER and cGMP 7

      FDA References 7

        ISPE 7

        GAMP 7

    Key Concepts 8

      Data Integrity 8

        ALCOA+ 8

        Database Systems 8

       Shared Responsibility Model 8

         Customer 8

         Software Vendor 9

         Consultants or System Integrators 9

         Cloud Service Providers 9

         Software/Platform as a Service (SaaS/PaaS) 10

         Ignition Best Practices 10

         21 CFR Part 11 Compliance 15

         Compliance Summary Table 15

         Compliance Detailed Description 17

         Subpart A - General Provisions 17

         Subpart B - Electronic Records 18

         Subpart C - Electronic Signatures 28

         Appendix A - References 34

         References 34

         Related References 34

         Related Resources (Global) 35

         Appendix B - Getting Started 36

         Review Guidance 3

 

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