PRISME Forum Meeting
CSV – Challenges and Opportunities from
Business/QA Perspective
Sid Senroy
Vice President - R&D Compliance
Biogen Idec
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My Background
Joined Biogen Idec in June 2011 as Global Head of R&D
Compliance
Current responsibilities - Oversee GCP, GLP and PV
Compliance
15 Years experience in big pharmaceuticals and biotech
industry (Schering Plough, Allergan, Elan) in multiple
roles within the Quality Assurance and IT organizations
Lead IT / CSV teams at Schering Plough, Allergan and
Elan for 7 years
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Challenges facing the industry
Perception that validation takes too much time and money
Business units often reluctant to upgrade existing systems or
switch applications
Industry still unclear of what is the “right / acceptable” level of
validation – What we develop in-house and what we use from the
vendor
Inability to upgrade or switch systems pose business risk
• Software vendor no longer supports application
• System not meeting business requirements
• Data security vulnerabilities
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Opportunities
Standardize approach to CSV especially for COTS
Embracing emerging technologies (i.e. Cloud
Computing) and defining the acceptable level of
validation
Collaborative Approach to Auditing
• Establish Focus Group to perform and share audit data
• Setup Confidentiality Agreement within the Focus
Group
• Define approach to Vendor Qualification and Routine
Audits
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