01 · One current version
There is one current version, and every link points at it
Each controlled document lives in one place. When a new revision is approved it takes the place of the old one at the same link, so every page, portal and bookmark that pointed at the document now points at the current version.
What this fixes
- Nobody can be certain which version is the one in force
- The quality team has become the search engine
- Controlled documents are spread across several systems
- Working from the wrong document can have serious consequences
1 in 10
FDA inspection observations against medical device quality systems relate to document control. FDA CDRH, Analysis of Inspection Observations, FY2017: 360 of 3,519 observations







