White Paper

Annex 11: The EU's New Expectations for Regulated Computerized Systems

Annex 11 is one of several guidance documents that supplement the EU's GMP rules governing medicinal products in the European union, which applies to all human and veterinary medicinal products made or sold in Europe. This white paper summarizes Annex 11 to clarify the guidelines for when a computerized system replaces a manual operation.
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