An adequate audit trail should be maintained to ensure that it can be demonstrated that the process was carried out completely and correctly.
It can also be beneficial to record additional information in the audit trail to assist with continuous improvement activities. For example, where an error is detected in an artwork during routine checking, it can be beneficial to capture reason “codes” for the errors in order to facilitate easier analysis of the process performance.
Typically, the audit trail would include the following:
• All approved documents, both specifying the requirements for change and the resulting artworks.
• Signature records from all approving stakeholders.
• The results of all critical quality checks.
A company needs to have a mechanism in place to ensure that the audit trail is maintained for the minimum period as required by local regulations and as defined in their corporate record retention policy. All audit trail records need to be kept in a manner that will prevent their loss in the event of such occurrences as fire or theft.
Look for evidence of audit records containing all of the above items when auditing artwork capabilities. Referring back to Tip 2, look for this evidence for all areas of the business, product groups, geographical regions, etc.
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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