Establishing a Continuous Process for FDA Software Validation

The FDA requires software validation for compliance with their Quality System regulation. Outlining how to achieve effective validation, the FDA’s General Principles of Software Validation recommends a comprehensive defect prevention strategy where software validation and verification activities such as peer code reviews, static analysis, unit testing, and regression testing are conducted throughout the entire software development life cycle.

With over 20 years of experience helping over half of the Fortune 500 companies incorporate these practices throughout the SDLC, Parasoft knows what it takes to rapidly bring organizations into FDA compliance and evolve a sustainable process for continued compliance. Parasoft is the industry leader in defect prevention—in fact, we wrote the book on it (Automated Defect Prevention, Wiley-IEEE, 2007).
Parasoft Quality Solutions support FDA compliance for C/C++, Java, and .NET by:

• Delivering the industry’s most comprehensive defect prevention and detection capabilities in an integrated solution: Parasoft provides out-of-the-box automation of the validation practices named in the FDA’s General Principles of Software Validation, including:
  
  
  
  • Static analysis -coding standards, data flow, metrics.
    
  • Dynamic analysis - unit/component testing, integration testing, functional testing, memory error detection, coverage analysis, continuous regression testing.
    
  • Peer code review (and document review) process automation.
    
  
  
• Orchestrating an end-to-end validation process that drives both automated and manual tasks: Having a combination of automated and manual validation tasks presents a distinct challenge in establishing a defined, repeatable, and traceable validation process. The challenge is further complicated by the fact that the precise sequence of actions which need to be performed depends on the results obtained at various decision points. Parasoft addresses these challenges by establishing an automated validation process that orchestrates the execution of all required planning, validation, and approval/sign-off tasks—both automated and manual—in the appropriate sequence, and with complete traceability.
  
• Integrating compliance tasks into the workflow across the SDLC: Parasoft establishes a continuous validation process that ensures compliance tasks begin early and are deployed across every stage of the SDLC, per FDA recommendations. To ensure that this process remains on track and does not disrupt project progress, Parasoft ingrains compliance tasks into the team’s existing workflow and automates them so team members can focus on tasks that truly require human intelligence.
  
• Facilitating issue remediation, not just issue detection: Each issue detected is prioritized, automatically correlated to the developer who introduced it, then distributed to his or her IDE with direct links to the problematic code. Eventually, developers start writing compliant code as a matter of habit. Moreover, through integration with the development infrastructure, results are correlated with requirements, bugs, and source code changes—converting data into actionable information.
  
• Delivering extensive reporting for documentation and process improvement: Our centralized reporting system provides real-time visibility into overall compliance status and processes, documents compliance efforts, and helps you determine what additional actions are needed to ensure continued compliance.
  

***
To read more, download the complete paper at http://www.parasoft.com/fda.

You can also access this paper at the Compliance Resources center.