Electronic System Posts

Do You Know Where Your Documents Are?

Mark Crawford

According to the FDA, six words not to utter on FDA inspection day are: “Now, where is that darn document?” (It’s nice the FDA has a sense of humor, at least on paper).

Kidding aside, this is a big-enough issue that the FDA recently offered a seminar to alleviate problems such as:

  • Unscanned paper documents
  • Confusing naming conventions
  • E-mails as documentation
  • Non-functional or non-existent SOPs
  • Missing documents

(more…)