An artwork capability is a complex interaction of different tasks, people, functions, and organizations that must come together to produce a result which is correct in minute detail. The process has to do this in an environment of constantly evolving regulatory requirements and business pressures. Therefore, there are going to be issues which arise or changes that need to be made to the process.

It is critical that a robust and formal issue management and continuous improvement process is in place. This process should be managed under the company’s Quality Management System and include such aspects as:
• Key Performance Indicators, including non-conformance.
• Short term user alerting of issues.
• Robust root cause analysis.
• Corrective action approval by appropriate cross-functional groups.
• Implementation management and tracking.

When auditing artwork capabilities, one should look for:
• Evidence that issues are captured and dealt with appropriately.
• Evidence of a development improvement plan.
• Evidence that Change Control is used to manage changes to the capability.


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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