Parasoft fda software compliance part1
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This document discusses FDA regulations for medical device software and how Parasoft Concerto can help with compliance. It notes that many medical device recalls are due to software defects introduced after release. The FDA provides guidance on software validation best practices including verification activities throughout the software development lifecycle (SDLC) and requirements traceability. Parasoft Concerto implements these practices by automating processes, providing visibility into activities, and enabling traceability between requirements, code, tests and validation scenarios. It also allows managing the software development process through policy-driven compliance checks.
Parasoft fda software compliance part1
- 1. Parasoft Quality Systems Automated Processes for FDA Software Compliance 2011
- 2. 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
- 3. 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
- 4. FDA Verification & Validation Software Verification Software Development Output meets Input Requirements Software Testing Static Analysis Dynamic Analysis Code Inspections Walkthroughs Others…
- 5. 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 upon comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage of the software development life cycle”
- 6. 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
- 7. 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”
- 8. Parasoft Concerto = FDA Compliance Processes and best practices that assists organizations to meet FDA guidelines and medical device industry standards for software development 1
- 9. Working Within IDE Deliver Tasks and Monitor Work
- 10. Project Overview Will it have the right functionality? on budget? project on time? Is your project Is your
- 11. Parasoft Concerto = FDA Compliance Processes and best practices that assists organizations to meet FDA guidelines and medical device industry standards for software development Control the Process Manage the Process 1 2
- 12. Iteration Overview Real-Time Traceability
- 13. Traceability – Natural Workflow Automated Traceability: Requirements are correlated to Tasks Tasks are correlated to Code… & Automated Tests… & Validation Scenarios
- 14. Parasoft Concerto = FDA Compliance Policy-Driven FDA Compliance allows you to manage the process by exception Manage By Exception 3 Control the Process Manage the Process 1 2
- 15. Policy Driven Compliance Productivity Verification Traceability More V&V Policies in Part2!
- 16. Policies for SDLC Management Will it have the right functionality? Red = Exception: Take Action Is you project on time? Yellow = Warning Is your project on budget? Green = On Track
- 17. Policies for Risk Management
- 18. Software Development Process Improvement A closed-loop process to manage and improve the software development lifecycle Manage By Exception 3 Control the Process Analyze and Improve Manage the Process 1 2 4
- 19. 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? Parasoft Proprietary and Confidential