Beyond FDA Compliance Webinar: 5 Hidden Benefits of Your Traceability Matrix

Beyond FDA Compliance: 5 Hidden Benefits of Your Trace

Matrix

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Speaker Bios

Steven R. Rakitin

President, Software Quality Consulting


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).

Topics

• Regulatory Requirements for Traceability

• Traceability Basics

• Requirements Trace Matrix (RTM) Benefits

• RTM Tool Validation

• References


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.


General Principles of Software Validation, FDA, Final Guidance, January 2002

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


General Principles of Software Validation, FDA, Final Guidance, January 2002

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.


Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005

Traceability Basics


• 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.

Traceability Basics


• 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.

Traceability Basics

• Typical Requirements Trace Matrix (RTM)

• Connection to issue management…


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…


RTM as a tool to Estimate Tests

• Use RTM early to estimate tests needed…


Provides Evidence Requirements Implemented


• Every SRS requirement maps to an SDD and to source code

Provides Evidence Requirements Tested

• Tests mapped to source code and requirements…


Provides Visibility for Managing Change

• Impact of change can be easily assessed…

• During development, use active links…


Provides Evidence Mitigations Implemented


HardwareFailure

OperatorError

InterfaceError

MemoryLeak Algorithm

errorUses

generictest strip

Doesn’t recognize

units

ExternalFactors

Thermistorfails

R14Shorts

SoftwareFailure

OROROR

Patient becomes hypoglycemic

OR

Incorrect Glucose ResultResult Delayed No Result

http://images.google.com/imgres?imgurl=http://img.alibaba.com/photo/200222026/Blood_Glucose_Meter_for_Health_Medical.jpg&imgrefurl=http://draco.en.alibaba.com/product/200222026-50170404/Medical_Implements/Blood_Glucose_Meter.html&usg=__3wi_VEp3YvGHagvEcvVtefFLgwQ=&h=745&w=634&sz=55&hl=en&start=20&tbnid=DoAI-7lCEymtEM:&tbnh=141&tbnw=120&prev=/images?q=home+use+glucose+meter&gbv=2&hl=en



Failure Modes and Effect Criticality Analysis (FMECA)

Harm: Patient Becomes Hypoglycemic Hazard: Incorrect Glucose Result


• Mitigations reflected in the design…

• Active links: specs mitigations in Risk Tables…


Seapine TestTrack Demonstration


Documentation

Documentation Implementation

Documentation Implementation Testing

Documentation Implementation TestingIssue

Management

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…


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

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


Beyond FDA Compliance Webinar: 5 Hidden Benefits of Your Traceability Matrix

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