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    One of the biggest FDA HOT BUTTONS is how a firm handles out of specification (OOS) lab results. Lab errors should be rare, and with this system, they will be.

    Just one OOS investigation will cost more than the price of this product. Using this system, it is estimated that at least 95% of all OOS results will be eliminated, and those that do occur, will generally be explainable.

    Order today and eliminate or greatly reduce regulatory exposure due to laboratory error.

    Save thousands of dollars in investigative costs and unwanted negative regulatory exposure.

    Avoid unnecessary Warning Letters and 483 Observations.

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      Continuous Process Improvement & Quality Systems for Regulated Industries

      NILSEN CONSULTING
      Phone: 207-762-1046


      Email: clnilsen@nilsenconsulting.com