The contract was written when my company was R&D based only and it states they will allow audit, but not on plant floor; We are now working under a Quality aspice as we move closer to FDA submission. A quality agreement and revised contract has not been finalized for these different expectations. I need to have objective evidence that we as a company have done our due diligence and auditted them against their procedures. They are a FDA regulated company also.
In layman's language, they can give us standard operating procedures saying they do this and that, but I have no way of verifying all. An example would be calibration, they procedure can say their equipment must be calibrated yearly, but I have no insight to looking at the equipment and seeing the calibration stickers.
I appreciate the advice.