1 / 2

Rocco Timpano – Sr Director IT Quality & Compliance – Governance, Risk, & Compliance

Rocco Timpano – Sr Director IT Quality & Compliance – Governance, Risk, & Compliance Christopher McElroy– Director IT Quality & Compliance – R&D/Medical Business Partner. IT QA – Perspective. Challenges and Opportunities New Technology (e.g. Cloud Computing)

roary-brennan
Télécharger la présentation

Rocco Timpano – Sr Director IT Quality & Compliance – Governance, Risk, & 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. Rocco Timpano – Sr Director IT Quality & Compliance – Governance, Risk, & Compliance • Christopher McElroy– Director IT Quality & Compliance – R&D/Medical Business Partner

  2. IT QA – Perspective • Challenges and Opportunities • New Technology (e.g. Cloud Computing) • Various Solutions (e.g. Definition of Public (external multi tenant) vs. Managed hosting (OOD) vs. Private (Internal Cloud)) • Mobil vs Medical Devices • (ref: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf) • Personal Computing Devices • Outsourcing (multi-Level) • Standards; Config Mgmt; Sub-sourcing; Vendor Auditing • Overlapping Compliance Requirements (Regulatory and Statutory) • (e.g. Multi Country BOH, Data Privacy, SOX) • 20th century CSV • Based on demonstrating control - where people knew where their hardware was located, what software had been loaded onto it and knew the names and qualifications of the personnel supporting their computing environment. Example: Who can log in? Do I know where my data is? Who can see my data? Is my data secure? • 21st Century CSV • Regulators allowing for adoption of a Risk Based approach. Opportunity (through PRISME) can a industry forum be formed to allow for the discussion, sharing, and leveraging risk based strategies with CSV.

More Related