1 / 1

Part 11 Compliance

Part 11 Compliance. FDA will inspect Part 11 controls relating to drugs as they are described in the ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (August 2003)

cybele
Télécharger la présentation

Part 11 Compliance

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Part 11 Compliance • FDA will inspect Part 11 controls relating to drugs as they are described in the ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (August 2003) • Findings from upcoming inspections will help us evaluate industry’s current compliance and understanding of Part 11 in light of the guidance (now over 6.5 years since finalized) • FDA may use the inspectional findings as part of its reevaluation of Part 11 regulation, guidance, etc. • FDA may take appropriate enforcement action for issues raised during these inspections

More Related