Mistake #3: Lack of Appropriate Document Controls The path of a document from its origin to its distribution must be known and controlled. It is not a could. It is not a should. Document control is a must for those documents that may be described as regulatory,...

Mistake #2: Untagged, Mislabeled and Misfiled Documents The Addendum in section 8.1 of the ICH E6 (R2) sums up this topic with brevity: “The storage system used during the trial and for archiving (irrespective of the type of media used) should provide...

Mistake #1: Storing your documents in multiple locations — resulting in not knowing where necessary documents are when they are needed. This is a very common occurrence originating with the source of the documents themselves. The fact is, key documents...