It brings the people and steps involved in artwork, such as marketing, regulatory, quality, packaging development, design studios and printers, into one controlled process, with a version history and an approval record. Many tools also manage assets and connect to regulatory or product data. Many systems manage the process rather than check the content, and verifying text, graphics, barcodes and print against the approved source is usually a separate step that needs its own evidence in a GxP setting.
Why it matters for labeling
A single place for the approved version and the approval record reduces version confusion, which is a leading cause of labeling errors. In a GxP environment, the system is itself a validated computerized system, so it needs an audit trail, access controls and compliant electronic signatures (see 21 CFR Part 11 and EU GMP Annex 11). It supports change control and keeps the master artwork identifiable.
Common mistakes
- Approvals given by email or on printouts outside the system
- Files replaced after approval without a new version
- Not validating the system or its integrations
- Assuming a workflow approval means the content has been verified against the source