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www.inea.com [email protected]
Boston: 100 Lowder Brook Drive, Suite 2500, Westwood, MA 02090 T: (781)801-1100Chicago: 475 Half Day Road, Suite 110, Lincolnshire, IL 60069 T: (773)915-2290
Leveraging Reusability & Traceability in Product Development
David A. Vogel, Ph.D. – President - Intertech Engineering Associates, Inc.
Larry Nicholson – Life Sciences Business Development – Seapine Software, Inc.
© 2012 – Intertech Engineering Associates, Inc.1
sponsored by
More detail …
2© 2012 – Intertech Engineering Associates, Inc.
Much of the content of this webinar is covered in more detail in this text book.
For more information, see www.validationtext.com
• This webinar will:– Introduce you to some basic concepts– Point out examples of benefits of traceability– Stimulate thinking about how more focus on
traceability would benefit your organization
• Unfortunately, too little time to dig into specific solutions
• Getting traceability right in your organization will take time
3© 2012 – Intertech Engineering Associates, Inc.
Setting Expectations
Traceability Mentioned in GPSV*
4© 2012 – Intertech Engineering Associates, Inc.
Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA
• General Principles of Software Validation, FDA Guidance Document
• Regulatory position … a soft “requirement”
• Little guidance on how or why
• Project Metrics• Are we designing the device right? (verification)
– Are all requirements implemented?– Are all requirements verified?– Are we meeting requirements of standards?
• Are we designing the right device? (validation)
– Are we meeting “stakeholder” needs?• Clinical, Marketing, Legal, Service, Manufacturing,
Risk Control, Usability• … and, yes, Regulatory
5© 2012 – Intertech Engineering Associates, Inc.
Benefits of Traceability
6© 2012 – Intertech Engineering Associates, Inc.
Sample Benefits - I
Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA
A
B
SOFTWAREREQUIREMENTS
DESIGNREQUIREMENT
7© 2012 – Intertech Engineering Associates, Inc.
Sample Benefits - II
Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA
A
B
SYSTEM LEVEL SOFTWARE
VERIFICATIONTESTS
SOFTWAREREQUIREMENTS
TRACE ORGANIZATION
8© 2012 – Intertech Engineering Associates, Inc.
Top Down
9© 2012 – Intertech Engineering Associates, Inc.
Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA
• Note top level design input sources
• Logical, predictable
Modified Top Down
10© 2012 – Intertech Engineering Associates, Inc.
Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA
• Design inputs often have “requirements” from variety of levels
• Efficiencies from reuse
11© 2012 – Intertech Engineering Associates, Inc.
Traceability/Reusability Ties Quality System to Project Specific Artifacts
SW Design & Dev. Policies(QSM)
62304 – SW
Lifecycle Standard
FDA – QSR820.30
FDA – G.P.S.V.
GuidelineSoftware
Development Process
Software Testing Process
Software Requirements
Software Design
Specifications
System Level Software Testing
Integration Level
Software Testing
Software Development
Plan
Software V & V
Plan
Difficult to Change Quality System General
Easier to Change Project Specific
Software Design
Specifications
Unit Level Software Testing
Decomposition of DHF Artifacts
12© 2012 – Intertech Engineering Associates, Inc.
System Level Software Test
Plan
System Level Test Plan Master uP - Functional
System Level Test Plan Master
uP - GUI
System Level Test Plan Safety uP - Functional
• Yes
• Ask yourself:– Why do I need this trace?– What benefit do we get from it?
• Document these answers
• If no benefit, why do it? (tracing can get “addictive”)
13© 2012 – Intertech Engineering Associates, Inc.
Is There Such a Thing As Too Much?
TRACE MORPHOLOGIES
14© 2012 – Intertech Engineering Associates, Inc.
Morphology Do’s and Don’ts
15© 2012 – Intertech Engineering Associates, Inc.
Reproduced with permission, from Medical Device Software Verification, Validation, and Compliance by David A. Vogel, Ph.D. © 2011 Artech House, Inc., Norwood, MA
METRICS AND TRACEABILITY
16© 2012 – Intertech Engineering Associates, Inc.
• How many requirements have been designed?
• How many requirements have verification tests written?
• How many tests have unresolved defects written against them?
• What is the average fan-out of requirements to design elements … requirements to verification tests?
17© 2012 – Intertech Engineering Associates, Inc.
Properly Designed Traces AllowSome Metrics
• Analyze current processes and tools
• Consider Intertech for helping to develop and improve processes and methods
• Consider Seapine Software for an integrated framework to support good processes and product development artifacts
18© 2012 – Intertech Engineering Associates, Inc.
Future Considerations
www.inea.com [email protected]
Boston: 100 Lowder Brook Drive, Suite 2500, Westwood, MA 02090 T: (781)801-1100Chicago: 475 Half Day Road, Suite 110, Lincolnshire, IL 60069 T: (773)915-2290
Questions & Answers
Please submit your questions via the Q&A panel
at the bottom right of your screen
© 2012 – Intertech Engineering Associates, Inc.19
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