We discussed the issue of ensuring that the evolution of a document is identified robustly in Tip 10. Having uniquely identified different versions of a document, the next thing to ensure is that everyone in the process is using the right version of a document at the right time.
Many errors have occurred in document management processes because individuals carried out their tasks correctly, but using the wrong version of a document.
The end-to-end artwork process and the supporting document repositories need to ensure that, at each stage of the process, individuals have access to and use the correct version of the documents. This may be through ensuring they are sent the right documents or, more ideally in our opinion, they have ready access to a secure document repository where they can confidently access the right version of the document.
When auditing artwork capabilities, ask how the process ensures that individuals use the correct version of a document at each stage of the process.
This is one in a series of blogs giving a view of the Top 20 things auditors should think about when reviewing packaging and labelling artwork management capabilities in the pharmaceutical, healthcare and other highly regulated industries. Please help me 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 www.be4ward.com. For a hard copy of the booklet, contact us at email@example.com.