Lack of or inadequate procedures for quality audits is a classic FDA compliance citation. Audit tools within the QMS are essential for keeping your audit schedule on track, consolidating checklists for easy access and ensuring prompt, efficient follow-up of any internal findings.
By streamlining the audit process with automated processes, you can save many hours on preparing for audits and processing findings. Not only that, you’ll also be better positioned to avoid many of the other citations listed in this post.