Activity

  • jjp93 replied to the topic What FDA Looks For In A Design Control System ? in the forum Introduction to Design Controls 6 years, 5 months ago

    I believe for a complete design control system, they will look at the correct signatures for the documentations and see if everything is timed properly. If an instrument is being used and has the same time for two different things, that can bring up questions about how everything is done and if all the documentations. They will also look at the meeting minutes and see how often design review meetings occurred to see if everything was done smoothly. If the minutes don’t have it then they will question whether it was actually done. They will come in to see how a procedure is done to make sure people are following the procedures and SOPs or are they taking shortcuts. They will review new SOPs and methods made to make sure they are valid. These are all important steps to make sure everything is risk free. They will definitely look into risk analysis and make sure there are no flaws.