Artwork Auditor Tip 15 – Are critical Information Technology tools managed under a Quality Management System?

Artwork Auditor Tip 15 – Are critical Information Technology tools managed under a Quality Management System?

Many Information Technology (IT) tools are often used to support a typical end-to-end artwork process.

Examples would include:

  • Artwork creation desktop
  • Electronic proof reading tools
  • Document management and electronic signature systems
  • Workflow tools
  • Barcode creation
  • Verification tools

As with any IT tools used to support a patient or product safety related process, an assessment of the risks that the tools present must be performed and the relevant Quality Management System used to ensure that those risks are managed effectively.

Typically, this risk assessment will result in most tools discussed above being considered critical and requiring management in a formal IT Quality Management System.

Anyone who has dealt with IT systems Quality Management Systems will understand that this is a complex area and we would recommend the reader consults experts in this field.

For each of the IT tools, look for evidence that a risk assessment has been carried out to identify those systems which must be managed under a Quality Management System. Where required, ensure that the systems have been validated and that they continue to be managed under an appropriate IT Quality Management System.

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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 www.be4ward.com. For a hard copy of the booklet, contact us at enquiries@be4ward.com

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