ARLINGTON, VA — As part of FDA’s Quality System Regulation (QS Reg) for medical devices, manufacturers must “validate” the software they use, meaning that in order to comply with the QS Reg, they must demonstrate that a piece of software is fit for its intended use.

Throughout the life of software that is used to automate regulated processes — such as the design, manufacturing, and packaging of devices — appropriate controls must be in place to ensure that the software performs as intended.

To help manufacturers navigate this rugged terrain, the Association for the Advancement of Medical Instrumentation (AAMI) has just published a new technical information report (TIR) called TIR36:2007, Validation of software for regulated processes, which offers guidance on appropriate software validation methods and tools.

Because FDA’s QS Reg already includes a regulation requiring manufacturers to validate software, TIR36 does not establish a new direction or new requirements for validation. Rather, the TIR is a collection of “best practices” reflecting the collective judgment of AAMI’s Validation of Software for Regulated Processes Task Group, which developed the TIR.

According to the TIR, the document “is a view of the issues from a device industry perspective, and a description of what many in the industry may already follow. It is meant to be a step toward better understanding the industry’s perspective on how to be compliant with the existing regulation in a value-added way.”

The document is intended for professionals in regulatory affairs, quality assurance, and software product/ process development who are involved in meeting FDA’s QS Reg, and who use software to automate any aspect of the quality system.