Executive Summary

PROCESS CONTROL SOFTWARE CHANGES: DOCUMENTATION should be a key concern of drug and device manufacturers, according to a technical report on software development activities recently released by FDA for use by its field investigators. An audit trail of records detailing the specific changes made to the system should be maintained by the firm. "From these records it should be possible to reconstruct the entire history of the software from the initial Requirements Phase to the installation of the current revision level," the reference for investigators notes. The main premise of the reference document is that "all categories of software should go through an organized development process consisting of a series of distinct phases which are collectively referred to as the software life cycle." The phases of the software life cycle, from the initial requirement phase to the operation and maintenance phase are described in separate chapters of the publication. Appendices are included on memory programming, software test methods, and references. In releasing the software reference to its field investigators, FDA emphasized that the document is not intended to establish FDA policy or investigational procedures. "It is not the intent of this document to serve as a medium for the establishment of new software development procedures, standards, or requirements and it should not be used as a basis for listing FDA-483 observations," the cover memo from FDA's Division of Field Investigations states. The preface to the reference explains that "ample industry standards and procedures" are already in the published literature. The intent of the its software publication, FDA states, is "to provide a synopsis of these requirements in a straightforward manner for use as a technical reference" by the FDA field staff. The software reference was drafted mainly by two FDA field investigators with computer expertise, John Kunkel and Philip Piasecki. During agency review, chapters discussing software development in relation to current GMPs and investigational procedures were removed. FDA is working on a separate "guideline" that will address these issues and be available for industry comment. FDA investigational interest in software GMPs was the focus of a recent meeting sponsored by the National Electrical Manufacturers Association (NEMA) in Washington, D.C. At that meeting, FDA investigator Martin Browning also emphasized the importance of a firm's software change control procedures, advising manufacturers to expect these procedures to receive attention during FDA inspections. The investigator will be interested in learning who decides when a change is necessary and why a certain modification method is chosen, Browning said. The investigator will also want information on the method used to implement the modification, the tests used to determine that the change was "incorporated correctly," as well as what the manufacturer did "to make sure that the change is not going to affect sections of the program or timing of the system." Browning discussed a draft of the technical reference at the NEMA meeting. In response to a concern that investigators would expect manufacturers to copy the software design model described in the technical reference document, Browning stated that the agency is not mandating that a manufacturer use a specific design procedure. FDA's concern is that the model chosen by the manufacturer "result[s] in a product that is fit for use and safe and effective."