Monthly Archives: December 2011

Artwork Auditor Tip 4 – Are critical control points adequately defined?

We have observed many artwork errors occurring because the artwork process has continued despite the fact that a previous stage of the process has not been fully completed. A typical artwork change management process will divide the development of new … Continue reading

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Artwork Auditor Tip 3 – Does a trigger for change result in all relevant artworks being changed?

One of the most basic causes of artwork error is not carrying out every change that is necessary as a result of a change trigger. For example, if a local regulator introduces a new packaging regulation requirement, one of the … Continue reading

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Artwork Auditor Tip 2 – Does the scope of the artwork management capability cover all labelling and artwork creation?

Once the existence of a Quality Management System (QMS) is established, the next thing to verify is that all artwork changes are managed within this framework. We have come across several situations where there was a good artwork capability in … Continue reading

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Artwork Auditor Tip 1 – Is the end-to-end artwork capability managed under a formal Quality Management System?

The packaging labelling and artwork management process in the healthcare industry creates an output which, if incorrect, can have serious implication on patient safety. Therefore, I would suggest that the artwork process must be managed under one or more formal … Continue reading

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Are Healthcare packaging labelling and artwork management capabilities key to meeting today’s business challenges?

Today, large Pharmaceutical and other Healthcare companies are arguably in the midst of the toughest challenges that they have ever faced. These challenges include: Blockbuster drug patents are expiring at an alarming rate and product development pipelines are not ready … Continue reading

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