The guide, whose second edition was published in 2022, sets out a lifecycle approach: scale validation effort to the risk a system poses to patient safety, product quality and data integrity, and make use of supplier documentation where it is reliable. It classifies software by how much it is configured or customized, which guides how much testing is needed. It is often used alongside regulatory expectations such as 21 CFR Part 11 and EU Annex 11.

Why it matters for labeling

Artwork comparison and label approval software is a GxP computerized system, so its validation is usually planned and documented using GAMP 5 concepts: a risk assessment, an intended-use specification, testing proportionate to risk, and a supplier assessment. How the software is classified affects how much of the vendor's documentation can be relied on.

Common mistakes

  • Treating GAMP 5 as a rulebook instead of a framework to apply with judgment
  • Over-testing low-risk functions while under-testing the functions that support release decisions
  • Accepting vendor documentation without checking it covers your intended use
  • Never reviewing the system after go-live

Sources