FEBRUARY 2008, Vol. 43, No. 2

New Software Guidance Available to Manufacturers

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, 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.

According to the TIR, for software validation efforts to be viewed as highly successful, the following should be true:

• The automated process or associated software functions as intended, without compromising device safety, device quality, and the integrity of the quality system.
• The people performing the necessary activities believe that the efforts are meaningful and worthwhile (least burdensome — most valuable activities).
• The manufacturer is in a state of compliance.
• Auditors and inspectors view the activities applied and the resulting records as acceptable evidence of compliance.