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ISO 9000 & AUDITS WORLD CONFERENCE

Usage and Validation of Cloud Technologies in a Regulated Environment

Presenter:   Pratima 'anu' Virkar, Head of Quality and Compliance IBM WHLS, IBM, Durham, NC, USA

Keywords: Cloud Validation

Industry: Food/Drug/Cosmetic

Level: Intermediate

ABSTRACT

Since SaaS is now an integral method of delivery for software which gathers, stores and manages clinical trial study data. In the past software was often deployed on single servers. With the advent of cloud technology SaaS deployments have grown. Issue with server redundancies are easily handled allowing for better disaster recovery.

Cloud technologies allow for more flexibility and better collaboration through enterprise wide systems allowing small business to provide big business service. However this opens up risks including but not limited to unrequested and sometimes undocumented automatic updates to the regulated systems, uncontrolled vendor outage, lack of internally trained staff to deal with issues if they arise, increased depended on cloud provider IT to trouble shoot and often loss of control of location of data. In addition to the issues mentioned above regulatory compliance becomes increasingly difficult. The purpose of this paper is to review some case studies and the unique challenges faced by emerging technologies in this domain.

Strategies that are used by both Cloud providers and customers will be presented with a view towards facilitating compliance through utilization of impact analysis documentation and automated testing.

Government Organizations




Corporations

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(*) based on previous conference attendance






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