FDA General Principles of Software Validation
The General Principles of Software Validation recommend a comprehensive software development lifecycle (SDLC) that integrates risk management strategies with principles for software validation. The FDA software validation principles are applicable to medical device software or software used to design, develop, or manufacture medical devices. Devices categorized as class II and III, as well as some class I devices are subject to design controls; of these class the following types of software must be validated for FDA approval:
- 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);
- Software used in implementation of the device manufacturer’s quality system (e.g., software that records and maintains the device history record).
TechExcel’s Devsuite accelerates approval by allowing companies to clearly define, document, verify and validate development activities and outcomes against the organization’s process. This of course is not enough; the FDA Software Validation standards prescribe the “Least Burdensome Approach”, an approach that can often give organizations “too much” freedom. Effectively allowing them to, “shoot themselves in the foot”, with their new processes. TechExcel helps you avoid these problems with predefined templates for implementing proven practices that have helped our other customers succeed. This means you can quickly build on the experience and success of others.