We see a lot of articles, seminars, webinars, presentations on the internet these days. Many tout to inform you and yours on the ills of Data Integrity issues. Sure this makes these services a quick buck, but seriously, can honesty be taught? What do you think?
Here is what the FDA says in a Warning Letter: “1. Identify any historical period(s) during which inaccurate data reporting occurred at your facilities. 2. Identify and interview your current employees who were employed prior to, during, or immediately after the relevant period(s) to identify activities, systems, procedures, and management behaviors that may have resulted… Read more »