The FDA General Principles of Software Validation

The FDA requires software validation for compliance with their Quality System regulation. Outlining how to achieve effective software validation, the FDA’s General Principles of Software Validation recommends a comprehensive software development lifecycle (SDLC) that integrates risk management strategies with principles for software validation.

An integrated SDLC integrates validation and verification activities such as peer code reviews, static analysis, unit testing, manual testing, and regression testing throughout the entire software development lifecycle. Parasoft supports the FDA’s vision of an integrated SDLC for C, C++, Java, and .NET with Parasoft Concerto for Medical Device Software Development.

This paper outlines what the FDA expects from software development organizations, and how Parasoft helps you meet those expectations.

Parasoft and FDA Software Validation

Parasoft Concerto is a Software Development Management platform which ensures that software can be produced consistently and efficiently with freedom from unacceptable risks. Parasoft Concerto for Medical Device Software Development is a pre-configured system with processes and best practices that assists organizations to meet FDA guidelines and medical device industry standards for software development.

Using Parasoft Concerto, organizations integrate project and task management with Automated Defect Prevention and end-to-end software verification and validation. The policy-driven platform helps you uniformly apply the least burdensome practices to mitigate the safety risks associated with your medical device applications.

Parasoft Concerto for Medical Device Software Development features:

• Built-in configurable templates for FDA, ANSI 62304, IEC, SIL and more
• Process, project, and task management
• Comprehensive requirements traceability
• Integrated defect prevention, validation and verification
• A continuous policy-driven compliance process with real-time visibility
• Correlation of all key artifacts, from tests, to requirements, to code, to builds, to project tasks

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).

Background: The FDA General Principles of Software Validation

Software validation is a requirement of the FDA Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.

The General Principles of Software Validation outlines general validation principles that the FDA considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. These validation requirements apply to:

• Software used as a component, part, or accessory of a medical device;
• Software that is itself a medical device (e.g., blood establishment software);
• Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
• Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

The following table provides a brief overview of what each section of the FDA General Principles of Software Validation recommends, and how Parasoft helps organizations satisfy those expectations...

To read more about what's expected for compliance with FDA General Principles of Software Validation sections 3, 4, and 5, get the complete Achieving FDA Software Validation Compliance white paper.