If it hasn’t been documented, it hasn’t been done and if you can’t find the documentation, it hasn’t been done. Documentation of method validation activities is required by FDA regulations. Using these documents as a basis for your facilities' documentation will help ensure compliance.

Download the accompanying presentations, "Writing Superior Analytical Documents," and "Developing Successful Method Transfer Strategies," presented at IVT's Validation and cGMP Compliance Week Puerto Rico, San Juan, Puerto Rico.