Which should you choose Is the choice working Stages of Decision Making

Which should you choose is the choice working stages

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Which should you choose? Is the choice working?
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Stages of Decision Making Intelligence When the individual collects information to identify problem occurring in the organization Design When the individual conceives of possible alternative solutions to a problem Choice When the individual selects among the various solution alternatives. Implementation When the individual puts the decision into effect and reports on the progress of the solution.
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1. Preliminary Investigation 3. Systems Design 5.Systems Implementation 2. Systems Analysis 6. Systems Maintenance 4. Systems Development System Development Life Cycle System Development Life Cycle
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Software Development Life Cycle (an Example)
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Planning Stage
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Requirements Definition Stage
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Design Stage
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Development Stage
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Integration and Test Stage
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Installation and Acceptance Stage
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Software Development Life Cycles: Outline for Developing a Traceability Matrix Software Life Cycle The FDA does not prescribe a specific software development life cycle, but requires manufacturers to identify and follow what makes sense for them Manufacturers choose a software life cycle model and development methodology appropriate for their device and organization Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 1998 Software Life Cycle must include: Risk management Requirements analysis and specification Design (both top level and detailed) Implementation (coding) Integration Validation Maintenance A software life cycle model should be understandable, thoroughly documented, results oriented, auditable, and traceable. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 1998 What is required to demonstrate traceability? Provide a traceability analysis or matrix which links requirements, design specifications, hazards, and validation. Traceability among these activities and documents is essential. This document acts as a map, providing the links necessary for determining where information is located. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 1998 How Does Traceability Ensure the Life Cycle is Followed? It demonstrates the relationship between design inputs and design outputs It ensures that design is based on predecessor, established requirements It helps ensure that design specifications are appropriately verified, that functional requirements are appropriately validated Important: Traceability is a 2-way street. Maintain "backwards" and "forwards" -- Tunnel Vision not acceptable in the Software Life Cycle!
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Traceability Across the Life Cycle Risk Analysis (Initial and Ongoing Activities) Trace potential hazards to their specific cause Trace identified mitigations to the potential hazards Trace specific causes of software-related hazards to their location in the software Requirements Analysis and Specification
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  • Fall '15
  • KHURRAM SHEHZAD

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