As we discussed in Tip 11, documents are likely to exist in a number of different formats and different individuals may need to deal with these different formats in different ways, e.g. images on screen, printouts.

It is essential that everyone viewing a document, in whatever format, is presented with an accurate rendition of the original document. Unfortunately, given the many software and hardware tools required to create and present these images, there are many opportunities for errors in the images to be introduced.

In the electronic space, standards such as Portable Document Format (PDF) were created to help address this issue. PDF is often used as an electronic mechanism by which documents in an artwork process are shared and the tools that are used to view PDF files can ensure accurate rendition when managed effectively.

When auditing artwork capabilities, look for evidence of IT risk assessments having been performed for the various document visualization methods used. For those risks identified, check to see that appropriate mitigating actions have been carried out.

The types of solutions that are often seen as a result of this sort of risk assessment include the use of specific tested and controlled printing routes and the use of controlled virtual desktop technology.


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.

To obtain an e-copy of our Top 20 Artwork Auditor Tips booklet, go to For a hard copy of the booklet, contact us at [email protected]

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