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Validating a computer system

Whatever your background, this book will help you quickly recognize problems and solutions that constantly recur, and apply this knowledge to new technologies and environments.

Coverage Includes · Data and networking transport · Lower- and higher-level transports and interlayer discovery · Packet switching · Quality of Service (Qo S) · Virtualized networks and services · Network topology discovery · Unicast loop free routing · Reacting to topology changes · Distance vector control planes, link state, and path vector control · Control plane policies and centralization · Failure domains · Securing networks and transport · Network design patterns · Redundancy and resiliency · Troubleshooting · Network disaggregation · Automating network management · Cloud computing · Networking the Internet of Things (Io T) · Emerging trends and technologies  Introduction Part I: The Data Plane Chapter 1: Fundamental Concepts Art or Engineering?

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Basic Requirements Computer system validation requires, first, that you obtain or design a process that can consistently conform to requirements; and then that you run studies demonstrating that this is the case.

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Hierarchical Design Common Topologies Ring Topologies Mesh Topologies Hub-and-Spoke Topologies Planar, Nonplanar, and Regular Final Thoughts on Network Design Patterns Further Reading Review Questions Chapter 23: Redundant and Resilient The Problem Space: What Failures Look Like to Applications Resilience Defined Other “Measures” Redundancy as a Tool to Create Resilience Shared Risk Link Groups In-Service Software Upgrade and Graceful Restart Dual and Multiplanar Cores Modularity and Resilience Final Thoughts on Resilience Further Reading Review Questions Chapter 24: Troubleshooting What Is the Purpose?

FDA: Examples of Computer Systems The FDA defines process validation as "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes." The objective of validation, therefore, is to produce documented evidence that parts of the facility will work correctly every time, when brought into use.

The goal is also to make sure that quality is built in to the system at every step; and not just a factor at the 'output' end of the process chain.

Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11.

It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.

274 comments

  1. An overview of Computer System Validation and why it is important when developing systems for pharmaceutical and healthcare industries.

  2. The structure of a GCP computer system, validation of the GCP platform and infrastructure systems, GCP software verification, and the quality assurance role in.

  3. Computerized system validation. Documented system requirements are required for CSV as they clearly stipulate the intended use of a computer system application.

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