The quality system is continually evolving, to address new regulations, new products, the growing business and changing business landscape.
Evolve and Change
Therefore, the documents which define the quality system will also need to evolve and change as these changes occur and therefore a document revision history for each document must be maintained which details the changes made at each revision.
Only the current revision is available to personnel and in use at points of use.
Multiple Revisions
It is never acceptable to have multiple revisions of a document available at the same time, but the history for each document is maintained.
These may be maintained on paper or electronically, provided the electronic system is validated.
Auditors will often ask for past revisions of documents to check to see if the changes were
documented accurately.
Revision History Table
In addition, it is very typical to include a revision history table as part of the document itself.
This is typically in the front or at the end of the document, but is important, particularly when documents are being used across organizations, such as with CMO’s or commercial partners, as the outside organizations likely do not have access to any the organizations internal document system and therefore rely on the revision history in the document to know what changes have occurred.