Data Integrity and Compliance With CGMP

PDA is pleased to provide comments to this docket and appreciates FDA's efforts to clarify their current expectations around Data Integrity with the questions and answers in this guidance document. Detailed comments are attached and a few general issues are highlighted below. With regards to the current draft we conclude data integrity concerns go well beyond quality control laboratories because data and metadata are generated in all departments. PDA recommends the scope of this guidance be enlarged to represent the spectrum of issues seen in warning letters and has made some specific suggestions in the attached comments. PDA also recommends FDA add a question and answer explaining the concept of data lifecycle for additional clarity and has provided a suggestion.