Computer System Compliance and Quality Planning

Quality planning as specified in the quality plan is critical to the success of a project. Despite its importance, the sufficiency of the project plan and its impact on quality planning are often not well understood. It has been surprising over the years to find that some project managers balk at pr...

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Bibliographic Details
Published in:Journal of GXP compliance 2011-01, Vol.15 (1), p.74
Main Author: O'Connor, Bernard T
Format: Article
Language:English
Subjects:
Compliance
Computer peripherals
FDA approval
Federal regulation
Managers
Planning
Project management
Quality control
Social support
Software quality
Success
Support groups
Systems design
Systems development
Total quality
User interface
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Summary:Quality planning as specified in the quality plan is critical to the success of a project. Despite its importance, the sufficiency of the project plan and its impact on quality planning are often not well understood. It has been surprising over the years to find that some project managers balk at preparing a project plan. There are multiple possible reasons for the absence of planning. Perhaps the project managers do not consider computer systems development as a process. For a software quality engineer or compliance professionals to be able to fully understand the development process of a computer system, they must first understand all of the elements of the system life cycle and the software development life cycle. The best start in achieving a computer system design that remains true to its original requirements is the preparation of solid and meaningful project and quality plans that unambiguously spell out a testable, compliant design.
ISSN:1552-5791
2150-6590