Tag Archive for Testing

Design Change: How Does FDA Define It?

Q: From an FDA viewpoint and your own experience, how would you recommend we define a “design change” in our design control procedures? A: FDA has said that any change to the finished, packaged and labeled device should be considered a design…

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Change Control for Software Updates

Q: We’re performing a Medra library update to our drug safety software and also considering changing a specification in our LIMS static data. In a regulated environment, do these functions require change control, or do you consider them merely maintenance issues?…

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