Beyond FDA Compliance: 5 Hidden
Benefits of Your Trace Matrix
Slide 1
Copyright © 2013 Software Quality Consulting Inc.
sp...
Speaker Bios
Steven R. Rakitin
President, Software Quality Consulting
Slide 2
Copyright © 2013 Software Quality Consulting...
Topics
• Regulatory Requirements for Traceability
• Traceability Basics
• Requirements Trace Matrix (RTM) Benefits
• RTM T...
Regulatory Basis for Traceability
• General Principles of Software Validation Guidance
– Software requirements traceabilit...
Regulatory Requirements for Traceability
• General Principles of Software Validation Guidance
Source code traceability ana...
Regulatory Requirements for Traceability
• Guidance for Pre-market Submissions Containing Software
– Traceability Analysis...
Traceability Basics
Slide 7
Copyright © 2013 Software Quality Consulting Inc.
• Forward Traceability
– Trace requirements ...
Traceability Basics
Slide 8
Copyright © 2013 Software Quality Consulting Inc.
• Backwards Traceability
– Trace each unique...
Traceability Basics
• Typical Requirements Trace Matrix (RTM)
• Connection to issue management…
Slide 9
Copyright © 2013 S...
RTM Benefits
• Provides a tool for estimating tests…
• Provides evidence all requirements are implemented…
• Provides evid...
RTM as a tool to Estimate Tests
• Use RTM early to estimate tests needed…
Slide 11
Copyright © 2013 Software Quality Consu...
Provides Evidence Requirements
Implemented
Slide 12
Copyright © 2013 Software Quality Consulting Inc.
• Every SRS requirem...
Provides Evidence Requirements Tested
• Tests mapped to source code and requirements…
Slide 13
Copyright © 2013 Software Q...
Provides Visibility for Managing Change
• Impact of change can be easily assessed…
• During development, use active links…...
Provides Evidence Mitigations Implemented
Slide 15
Copyright © 2013 Software Quality Consulting Inc.
Hardware
Failure
Oper...
Provides Evidence Mitigations Implemented
Slide 16
Copyright © 2013 Software Quality Consulting Inc.
Basic Events Prelimin...
Provides Evidence Mitigations Implemented
• Mitigations reflected in the design…
• Active links: specs  mitigations in Ri...
Seapine TestTrack Demonstration
Slide 18
Copyright © 2013 Software Quality Consulting Inc.
RTM Tool Validation
• All software tools are subject to requirement for software validation,
but validation approach used ...
Training Available from SQC
• Software Development for Medical Device Manufacturers
• Medical Device Risk Management
• Sof...
Thank you!
Slide 56
If you have questions, please call or e-mail...
Copyright © 2013 Software Quality Consulting Inc.
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
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Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
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Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
Sw qual joint webinar deck (5)
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Sw qual joint webinar deck (5)
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When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission—too late to capture the benefits a well-maintained matrix can deliver.

During this recorded webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, discussed five of the benefits gained by maintaining a matrix throughout the project. A software engineer with more than 20 years of experience in the medical device industry, Steve explains how a trace matrix can help you:

- Plan and estimate testing and validation needs
- Ensure all requirements are implemented
- Verify that all requirements have been tested
- Manage change throughout product development
- Provide evidence that hazard mitigations are implemented and validated

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Sw qual joint webinar deck (5)

  1. 1. Beyond FDA Compliance: 5 Hidden Benefits of Your Trace Matrix Slide 1 Copyright © 2013 Software Quality Consulting Inc. sponsored by
  2. 2. Speaker Bios Steven R. Rakitin President, Software Quality Consulting Slide 2 Copyright © 2013 Software Quality Consulting Inc. Michael C. Sieve Life Sciences Solution Engineer, Seapine Software • 10 years experience in compliance industries, including life sciences, government, utilities, and aviation. • Certified Master Black Belt in Lean Six Sigma, Software Validation, Risk Management, and Negotiation. Well versed in the General Principles of Software Validation and Part 11 Compliance. • 35 years experience as a software engineer and software quality manager. • Senior member of the IEEE Computer Society, ASQ Software Division, ASQ Biomedical Division, and the Association for the Advancement of Medical Instrumentation (AAMI). • Helped write the first IEEE Software Engineering Standard (IEEE-STD-730 Standard for Software Quality Assurance Plans) and is currently a committee member working on revisions to both IEEE Standard 1012 (Software Verification & Validation) and 730 (Software Quality Assurance).
  3. 3. Topics • Regulatory Requirements for Traceability • Traceability Basics • Requirements Trace Matrix (RTM) Benefits • RTM Tool Validation • References Slide 3 Copyright © 2013 Software Quality Consulting Inc.
  4. 4. Regulatory Basis for Traceability • General Principles of Software Validation Guidance – Software requirements traceability analysis should be conducted to trace software requirements to (and from) system requirements and to risk analysis results. – Traceability analysis should be conducted to verify that software design implements all of the software requirements. – As a technique for identifying where requirements are not sufficient, the traceability analysis should also verify that all aspects of the design are traceable to software requirements. Slide 4 Copyright © 2013 Software Quality Consulting Inc. General Principles of Software Validation, FDA, Final Guidance, January 2002
  5. 5. Regulatory Requirements for Traceability • General Principles of Software Validation Guidance Source code traceability analysis is an important tool to verify that all code is linked to established specifications and established test procedures. Source code traceability analysis should be conducted to verify that: – Every element of software design descriptions (SDD) has been implemented – Source code traces back to elements in SDD and to risk analysis – Tests trace to elements in SDD and to risk analysis – Tests trace to source code Slide 5 Copyright © 2013 Software Quality Consulting Inc. General Principles of Software Validation, FDA, Final Guidance, January 2002
  6. 6. Regulatory Requirements for Traceability • Guidance for Pre-market Submissions Containing Software – Traceability Analysis links together product design requirements, design specifications, and testing requirements. – Also provides a means of tying together identified hazards with implementation and testing of mitigations. – Traceability Analysis commonly consists of a matrix with line columns for requirements, specifications and tests, and pointers to hazard mitigations. – Submit for review explicit traceability among these activities and associated documentation as they are essential to effective product development and to reviewer’s understanding of product design, development and testing, and hazard mitigations. Slide 6 Copyright © 2013 Software Quality Consulting Inc. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
  7. 7. Traceability Basics Slide 7 Copyright © 2013 Software Quality Consulting Inc. • Forward Traceability – Trace requirements from User Needs and System Specification through software requirements, design, test, and hazard documents to ensure medical device addresses needs of clinicians and patients. – Benefits include ensuring all requirements are implemented in design and code and that all requirements are covered by tests.
  8. 8. Traceability Basics Slide 8 Copyright © 2013 Software Quality Consulting Inc. • Backwards Traceability – Trace each unique work product (e.g., design element, object/class, source code unit, test, etc.) back to its associated requirement source(s). – Backward traceability verifies that: • Design and implementation match specifications and intent • Requirements are current with changes to design, hazard analysis, source code, bug fixes, and tests.
  9. 9. Traceability Basics • Typical Requirements Trace Matrix (RTM) • Connection to issue management… Slide 9 Copyright © 2013 Software Quality Consulting Inc. User Needs Document System Spec SRS SDD Source Code Unit Tests Integration Tests System Validation Tests Design OutputsDesign Inputs Tests
  10. 10. RTM Benefits • Provides a tool for estimating tests… • Provides evidence all requirements are implemented… • Provides evidence all requirements have been tested… • Provides visibility for managing changes throughout product development… • Provides evidence hazard mitigations are implemented and validated for effectiveness… Slide 10 Copyright © 2013 Software Quality Consulting Inc.
  11. 11. RTM as a tool to Estimate Tests • Use RTM early to estimate tests needed… Slide 11 Copyright © 2013 Software Quality Consulting Inc. User Needs System Spec SRS Estimated Validation Tests Req’d Types of tests Existing Validation Tests New Tests to be written User Need 100 System 200 User Login SRS 440 10 3-Positive 2-Negative 5-Boundary VAL 4400 VAL 4500 VAL 4600 User Need 110 System 220 Power-on SRS 450 8 2-Postive 1-Negative 5-Boundary None VAL 8000 VAL 8010 VAL 8020 TOTAL ESTIMATED TESTS 150 80 70
  12. 12. Provides Evidence Requirements Implemented Slide 12 Copyright © 2013 Software Quality Consulting Inc. • Every SRS requirement maps to an SDD and to source code User Needs System Spec SRS SDD Source Code Unit Tests Integration Tests System Validation Tests User Need 100 System 200 User Login SRS 440 SDD 550 login.c UT 100 INT 330 VAL 4400 VAL 4500 VAL 4600 User Need 200 System 220 Power-on SRS 450 SDD 560 bit.c UT 200 INT 440 VAL 8000 VAL 8010 VAL 8020 TOTAL ACTUAL TESTS 204 139 173
  13. 13. Provides Evidence Requirements Tested • Tests mapped to source code and requirements… Slide 13 Copyright © 2013 Software Quality Consulting Inc. User Needs System Spec SRS SDD Source Code Unit Tests Integration Tests System Validation Tests User Need 100 System 200 User Login SRS 440 SDD 550 login.c UT 100 INT 330 VAL 4400 VAL 4500 VAL 4600 User Need 200 System 220 Power-on SRS 450 SDD 560 bit.c UT 200 INT 440 VAL 8000 VAL 8010 VAL 8020 TOTAL ACTUAL TESTS 204 139 173
  14. 14. Provides Visibility for Managing Change • Impact of change can be easily assessed… • During development, use active links… Slide 14 Copyright © 2013 Software Quality Consulting Inc. User Needs System Spec SRS SDD Source Code Unit Tests Integration Tests System Validation Tests User Need 100 System 200 User Login SRS 440 SDD 550 login.c UT 100 INT 330 VAL 4400 VAL 4500 VAL 4600 User Need 200 System 220 Power-on SRS 450 SDD 560 bit.c UT 200 INT 440 VAL 8000 VAL 8010 VAL 8020 TOTAL ACTUAL TESTS 204 139 173
  15. 15. Provides Evidence Mitigations Implemented Slide 15 Copyright © 2013 Software Quality Consulting Inc. Hardware Failure Operator Error Interface Error Memory Leak Algorithm error Uses generic test strip Doesn’t recognize units External Factors Thermistor fails R14 Shorts Software Failure OROR OR Patient becomes hypoglycemic OR Incorrect Glucose ResultResult Delayed No Result
  16. 16. Provides Evidence Mitigations Implemented Slide 16 Copyright © 2013 Software Quality Consulting Inc. Basic Events Preliminary Risk Assessment Mitigation Information Residual Risk Assessment Basic Event Failure Modes Severity Likelihood Risk Index Mitigation Verification (Implemented) Validation (Effective) Severity Likelihood Risk Index Memory Leak Coding error Critical Frequent Very High Memory leak detection added to SRS 4.2.2.3 Refer to code review minutes dated 8/14/13 System test SYS-2245 shows no memory leaks Critical Occasional Moderate Resistor R12 fails Age or wearout Critical Probable High Built-in test (BIT) to check R12 added to SRS 4.6.5.3.1 Refer to code review minutes dated 8/15/13 System test SYS-3020 shows R12 failure detection by BIT Critical Very Low Low Failure Modes and Effect Criticality Analysis (FMECA) Harm: Patient Becomes Hypoglycemic Hazard: Incorrect Glucose Result
  17. 17. Provides Evidence Mitigations Implemented • Mitigations reflected in the design… • Active links: specs  mitigations in Risk Tables… Slide 17 Copyright © 2013 Software Quality Consulting Inc. User Needs System Spec SRS SDD Source Code Unit Tests Integration Tests System Validation Tests User Need 100 System 200 User Login SRS 440 SDD 550 login.c UT 100 INT 330 VAL 4400 VAL 4500 VAL 4600 User Need 200 System 220 Power-on SRS 450 SDD 560 bit.c UT 200 INT 440 VAL 8000 VAL 8010 VAL 8020 TOTAL ACTUAL TESTS 204 139 173
  18. 18. Seapine TestTrack Demonstration Slide 18 Copyright © 2013 Software Quality Consulting Inc.
  19. 19. RTM Tool Validation • All software tools are subject to requirement for software validation, but validation approach used for each application can vary widely. • Risk-based approach is widely used AAMI TIR 36:2007 provides guidance on validation of software tools… Slide 54 Copyright © 2013 Software Quality Consulting Inc. Risk Category Tool Description Some examples High Tool output directly affects embedded software structure, supplies data or constants used in device, or affects configuration… Memory (EPROM or Flash) programming tools, calculation tools (spreadsheets, etc.), Moderate Tools that support Design Controls and the Quality System RTM, Doc control, source code control, bug tracking, complaint handling, CAPA, etc. Low General purpose tools used to support the product development process Word processing, spreadsheet, presentation
  20. 20. Training Available from SQC • Software Development for Medical Device Manufacturers • Medical Device Risk Management • Software Verification & Validation • Computer System Validation • For more information, please visit www.swqual.com Slide 55 Copyright © 2013 Software Quality Consulting Inc.
  21. 21. Thank you! Slide 56 If you have questions, please call or e-mail... Copyright © 2013 Software Quality Consulting Inc.
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