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Meeting your
regulatory
requirements just got easier...
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| Computer-controlled
equipment and processes have been steadily increasing since the
early 1980's. Increasing output, improving productivity, and
reducing labor costs are some of the benefits of using software to
automate and control manufacturing processes. Today's manufacturers
cannot assume that purchased systems are properly documented
and validated. Ensuring that software applications consistently
produce a product in order to meet its pre-determined specifications
and quality attributes is the goal of software and process
validation activities. Key
Benefits
 Supports maintainability
Provides a basis for testing
Communicates design and interfaces to other
engineering groups
Communicates design/implementation to other programmers
Provides a basis for quality evaluation, e.g., QA, independent
testing, program management
Allows application structured software design methods
Provides continuity if original programmers leave
Increased customer satisfaction
Higher level of professionalism
Capabilities
Plans
- Does "ready, fire, aim" sound a
little too familiar? Taking the time to identify which aspects
of the software lifecycle methodology need documentation will
save time, money, and will ultimately decrease time-to-market.
Software Quality Assurance Plans (SQAP) will identify the plans
and activities performed by the Software Quality Assurance
staff. Configuration Management Plans (CMP) describe the
methodology used to establish and change the functional and
physical characteristics of a configuration item, and describes
how the reporting for change processing and implementation are
handled. The Verification & Validation Plan, sometime
called a Test Plan, defines the approach for the conduct of the
review and testing activities.
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Software Requirements Specification
- The Software Requirements Specification (SRS)
identifies functional, performance, and interface requirements
for a software component. The SRS specifies applicable
development standards and provides a baseline for system
testing/validation. In essence the SRS identifies "what"
the software is to do.
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Software Design Documentation
- Defines the program architecture, identifies
algorithms, control logic, data structures, input/output
formats, and interface protocols. The SDD essentially identifies
"how" the software is to be implemented.
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Test Documentation
- Test Procedures provide detailed instructions
for the setup, operation, and conduct of the test activities.
Test Reports describe the results of the completed tasks.
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