Preparation for an audit, it is important to assess the documentation that was prepared when each GxP system was validated to identify and remediate any gaps…

The concept paper gives a valuable comment on current annex 11. All the practical issues and practices are summarized here. Please go through the video and t…

Reasons for the revision of Annx 11 include, but are not limited to the following (in non-prioritized order and with reference to existing section in sharp bra…