You have never validated your process because you just don’t have the staff or expertise to do it. You notice that the FDA is really starting to crack down on process validation and you are concerned that you have fallen behind.
We understand process validation and how to apply it in many settings. We can assist you in detecting the presence and degree of variation in your processes, and understand the impact of the variation on the process and ultimately on the product. We can help you establish risk for your process through the use of Process Failure Modes and Effect Analysis (PFMEA) or other risk assessment tools , and then apply risk scores and statistical methods to determine the appropriate sample size. Before you begin the Process Performance Qualification (PPQ) stage, we will ensure that your equipment and test methods are appropriately validated.