THE IMPACT OF PART 11 ON PROCESS ANALYTICAL TECHNOLOGY
This article was originally published in The Gold Sheet
Executive Summary
...is being considered as FDA and industry seek to remove obstacles to implementation of the new on-line control systems. The issue was a focal point at an agency advisory committee meeting in late October. Industry experts asserted that Part 11 electronic record controls should only apply to critical data, not raw data, to avoid being overwhelmed by the surge of information that will be generated by PAT systems. Overly strict computer validation expectations are seen as another PAT obstacle. Inspection citations regarding computer system validation and security, such as those recently levied against Eli Lilly, add to the industry concern.