Medical Devices Compliance
How to Deal with the Contradictions and Challenges of Using Cloud in a Regulated Environment
The evolution of computerized technologies has been both amazing and challenging. Each new wave of technological evolution has been accompanied by a series of compliance challenges, and subsequent strategies to comply with applicable regulatory requirements. Cloud computing is a current example of this evolution. This presentation will provide a discussion of Cloud concepts, terminology, definitions, architecture, and services; review the contradictions and challenges of using a cloud environment to support regulated activities; discuss assessments of cloud hosting facilities; and stress the importance of a detailed Service Level Agreement (SLA).
Understanding the Cloud Definition
The Basics – Architecture & Services
Contradictions and Challenges
Cloud Provider Assessments
Compliance – Past, Present, Future
The Service Agreement
Closed vs. Open Systems
Perspective / Compliance Notes / Conclusions
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.
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