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Tuesday, June 28 • 2:00pm - 3:15pm
#239: Cloud Compliance: Clinical Software Challenges and Vendor Auditor Views

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Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

We will share practical experience and tips for addressing the compliance challenges for clinical solutions using cloud technology and auditing vendors of IaaS, PaaS, and SaaS services. Benefits, challenges, and possible remediation are discussed.

Learning Objectives

Identify infrastructure issues related to data integrity and system security for SaaS, IaaS, and PaaS services; Discuss audit compliance issues related to cloud based software solutions; Identify how to check for critical quality evidence based on 50+ audits of IT suppliers.


Teri Stokes, PhD, MS, MT


Software as a Service (SaaS) and Cloud Provider Qualification: An Auditor's Perspective
Calvin H Kim, MS

Maintaining the Validation Status of Software as a Service (SaaS) in a Regulated Environment
Anu Virkar

Are You Cloud Compliant? Practical Considerations for Managing Clinical Data in the Cloud
Srinivas Karri, MSc

avatar for Teri Stokes

Teri Stokes

Director, Quality Assurance Compliance, Cytel Inc.
Dr. Stokes worked 11 years as a Medical Technologist in hospital, research, and central medical laboratories. Then 16 years at Digital Equipment Corporatin (DEC) first in the Large Computer Group, second in the Laboratory Data Products Group, and finally at DEC in Basel, Switzerland doing Computer Validation consulting across Europe. Since 1996 she has had her own computer validation consultancy GXP International. Author of 3 books and many... Read More →


Srinivas Karri

Director, Clinical Warehousing Cloud Strategy, Oracle Corporation
As an industry strategy lead for clinical data cloud based applications, I help identify, define and create new services to support management of clinical data using cloud based technologies and capabilities. I have over 20 years experience with developing, implementing, selling and supporting clinical data applications for a diverse set of life sciences companies.
avatar for Calvin Kim

Calvin Kim

Senior GxP IT Auditor, Bayer HealthCare Pharmaceuticals
Calvin is a seasoned IT auditor with over 20 years of experience in various sectors of GxP regulated industries. As a core member of a global QA organization responsible for quality oversight and regulatory compliance assessment of computerized systems (CS) and technologies used in pharmaceutical, consumer health, animal health, and medical device sectors across a global organization, he has completed more than 100 evaluations and audits of IT... Read More →
avatar for Anu Virkar

Anu Virkar

Vice President, Quality and Compliance, Merge, eClinical An IBM Company
Anu Virkar, MS, MA, PMP is the VP of Q&C at Merge eClinical. Anu has been in the SQA field for over 23 years, & has focused on clinical trial mgmt and med device industry for over 12 yrs. She has extensive experience in software QA, SDLC, project mgmt as well as policy development, implementation. She has obtained ISO9000 certification. Anu is well versed in regulatory guidelines that govern pharma &med device & has exceptional track record of... Read More →

Tuesday June 28, 2016 2:00pm - 3:15pm
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA