The FDA clearly gives you two options;
1- Create a DMR document for each finished good you have in your facility that includes all the different components of the finished good and you know this includes but it is not limited to, prints, labels, routings, material specs, quality specs, packaging specs, inspection procedures, fixtures, bill of materials, maintenance documents, etc... If your company has many finished goods this is a nightmare and I would use option 2.
2. Create one document and include a table that shows each specific document or component of the DMR in the first column and shows ITS LOCATION in the second column. i.e. Drawings > location could be a master file with hardcopies or it could be an electronic directory or attached to the Document Control Software Database (Oracle, Documentum, Agile, etc...) If you have over 100 finished goods go with this option is the easiest one.
The DHR and DMR are related since the documents in the DHR used to manufacture an item at a specific time must match the revision of the DMR at that specific time. i.e. If I have a DHR record of 1999 the documents inside the DHR record must match the revision listed for all the components at that same specific date in 1999. Its simple if you have any more questions contact me victorjlebron at hot