White Papers for Food and Drug Administration (FDA)

Amgen Gets Cure for Documentation Woes

Aldon

As a leading producer of therapeutic pharmaceuticals and manufacturer of recombinant and bio-engineered drugs, Amgen must comply with strict FDA regulations. Among the requirements is the need to document and track all changes made to the AS/400 or iSeries systems and software. To help manage that process, Amgen uses Aldon Lifecycle Manager (iSeries Edition), Aldon's change management solution for the iSeries.

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