We live in a world where we constantly deal with documents in different interchangeable formats. Rarely are the documents we deal with today created on paper, normally they are created electronically and shared using a number of different electronic and paper formats. Artwork and it’s associated documents are no different.
It must be recognized that different documents may need to be prepared using different software tools, e.g. MS Word for source text documents, Adobe Illustrator for artwork, etc. It is often not practical or desirable to share these “native” documents using their creation tools. Therefore, facsimiles of these native documents are created and shared (see Tip 16). This immediately creates different forms of the same document.
Also, electronic documents may need to be printed, signed, scanned and submitted into an electronic records system. This again creates other forms of the same document.
What must be ensured in the process of dealing with these various forms of a document is that everyone is seeing the same thing when they should be.
When auditing artwork capabilities look for procedural evidence that the methods by which users view documents, particularly during review and approval are defined. This will typically be on screen or via printout.
From an information technology perspective, look for evidence that the risks of errors being introduced in rendering artwork images and printouts have been considered and that the appropriate risk mitigations have been put in place.
This is one in a series of blogs giving a view of the Top 20 things auditors should think about when reviewing packaging and labeling artwork management capabilities in the pharmaceutical, healthcare, and other highly regulated industries. Please help us improve the thinking by adding your comments and share this with others who may have a view.