Different sectors use different standards. Medical device manufacturers follow ISO 13485 and FDA's QMSR, medicine manufacturers run a pharmaceutical quality system based on EU GMP Chapter 1 and ICH Q10, and many other organizations use ISO 9001. An electronic QMS (eQMS) is software that manages elements such as documents, deviations, CAPA, change control and training.

Why it matters for labeling

Labeling processes live inside the QMS: document control, change control, deviations, supplier control and records. A labeling error is a quality event, handled through the QMS and, where needed, a CAPA. If labeling procedures or artwork files sit outside the system, the evidence an inspector asks for is scattered, and the controls that protect the approved version don't apply.

Common mistakes

  • Labeling procedures kept separate from the QMS
  • Artwork files held outside document control
  • Labeling errors closed without a CAPA or a root cause
  • Suppliers such as printers and agencies not covered by supplier control

Sources