As with all document management activities, it is essential that everyone is clear which iteration of a document needs to be used at any particular time in the process.
Many errors have occurred in artwork management processes because this has not been clear. For example, necessary changes have been accidentally omitted because a previous iteration of a document was carried forward in the process. Alternatively, approvals can be incorrectly given if the wrong iteration of a document is used by the approver.
One solution to this problem is to ensure that there is a robust document revision numbering system put in place which:
• Ensures that each iteration of a document is given a unique revision or version number.
• Each and every time a document is modified in any way, that it’s revision or version number is changed.
In this way there will be a high degree of confidence that all iterations of a document can be clearly identified to everyone concerned.
When auditing artwork management processes, look for procedures which govern how revisions to documents will be managed. Pay particular attention to areas of the process where small changes to artworks may occur on a regular basis and ensure that unique version numbering is applied here as well.
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.
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