parasoft fda software compliance part1
DESCRIPTION
Parasoft Quality SystemsAutomated Processes for FDA Software ComplianceTRANSCRIPT
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Parasoft Quality SystemsAutomated Processes for FDA Software Compliance
2011
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Why the need for Regulation?
FDA Analysis Reveals:
� 3,140 Medical Device Recalls (1992-1998)
� 242 (7.7%) attributable to Software Failures
� 192/242 (79%) caused by software defects introduced when changes were made to the software after release
Software Validation Best Practices
A principle means of Avoiding such Defects & Resultant Recalls
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FDA Guidance on Software Compliance
“General Principles of Software Validation”
� Based on generally recognized software validation principles
� Lists elements acceptable to FDA for Software Validation
� Recommends conducting Verification Activities throughout the SDLC
� Recommends integration of SDLC Mgt & Risk Mgt activities
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FDA Verification & Validation
Software Verification
� Software Development Output meets Input Requirements
� Software Testing
� Static Analysis
� Dynamic Analysis
� Code Inspections
� Walkthroughs
� Others…
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FDA Verification & Validation
Software Validation
� The Software consistently fulfills all of the requirements, which in turn meet the end users needs
� Traceability
“…the validation of software typically includes evidence that all software requirements have been implemented correctly and completely and are traceable to system requirements”
� Visibility
“A conclusion that software is validated is highly dependent uponcomprehensive software testing, inspections, analyses, and otherverification tasks performed at each stage of the software development life cycle”
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FDA Compliance – Summary
� A set of Effective Software Verification Activities
� Should be performed Throughout the SDLC
� Outside Visibility into these regular Activities (Audit)
� Full Requirements Traceability
� Effective Regression Tests for Post-Release Code Changes
� Data Collection, Correlation & Report Generation (Audit)
� Process Improvement
� Integration of SDLC Management and Risk Management
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One Final Consideration…
“FDA Worried That Class I Recall Jump Reflects Industry Rush To Market”
Article preview from "The Gray Sheet"- May 24, 2010
“A recent spike in Class I medical device recalls has led FDA to question whether manufacturers are sacrificing
quality to rush products to market”
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Parasoft Concerto = FDA Compliance
Processes and best practices that assists organizations to meet FDA guidelines and medical device industry standards for
software development
1
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Working Within IDE
Deliver Tasks and Monitor Work
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Project Overview
Is your project on time?Is your project on budget?Will it have the right functionality?
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Parasoft Concerto = FDA Compliance
Processes and best practices that assists organizations to meet FDA guidelines and medical device industry standards for
software development
1Manage the Process 2Control the Process
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Iteration Overview
Real-Time Traceability
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Traceability – Natural Workflow
& Validation ScenariosTasks are correlated to Code… & Automated Tests…
Automated Traceability: Requirements are correlated to Tasks
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Parasoft Concerto = FDA Compliance
Policy-Driven FDA Compliance allows you to manage the process by exception
1Manage the Process
3Manage By Exception
2Control the Process
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Policy Driven Compliance
Productivity
Verification
Traceability
More V&V Policies in Part2!
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Policies for SDLC Management
Red = Exception: Take Action
Will it have the right functionality?
Is you project on time?
Yellow = Warning
Green = On Track
Is your project on budget?
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Policies for Risk Management
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Software Development Process Improvement
A closed-loop process to manage and improve the software development lifecycle
1Manage the Process
3Manage By Exception
Analyze and Improve42
Control the Process
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Parasoft Proprietary and Confidential
Real-Time FDA Process Compliance
FDA Software Validation Compliance
� Verification and Validation
� Best Practices, Visibility & Traceability
Parasoft Concerto, the infrastructure for FDA compliance
plus real-time data that tracks:
� Is your project on time?
� Is your project on budget?
� Will it have the right functionality?
� Will it work?