Session ID: Prepared by: Remember to complete your evaluation for this session within the app! 11229 Managing Product Lifecycle Complexities in Pharma How Oracle Agile could improve productivity and compliance 04/08/2019 Arun Sharma NexInfo Solutions
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Session ID:
Prepared by:
Remember to complete your evaluation for this session within the app!
11229
Managing Product Lifecycle
Complexities in Pharma
How Oracle Agile could
improve productivity and
compliance
04/08/2019
Arun Sharma
NexInfo Solutions
Who is NexInfo?
SUMMARY
• Consulting company focused on helping clients achieve Operational Excellence via an optimal blend of Business Process &
Software consulting services
• Deep domain expertise, including: Integrated Business Planning (IBP/S&OP), Enterprise Resource Planning (ERP), Product
Processes Enabled: • Country Specific BOMs/Materials
• Country Specific Labels/Artwork
• Country Specific Packaging
• Product License Tracking/Expiry
Go from Unstructured Paper to Structured Specifications
Unstructured Papers to Integrated Global System
Single Source of Truth for all Clinical & Commercial Items
Item Template
Raw Materials Clinical API
Clinical WIP (Bulk) Clinical Britestock
Clinical Finished Good Clinical Packaging & Labeling
Commercial API Commercial Bulk (Tablet, Liquid)
Commercial Britestock Commercial Finished Good
Commercial Packaging & Labeling
GPLM KPI Metrics
The system has been in production for over 150 days and has more than 1,000 users across five Gilead
sites. The diagram below summarizes the clinical and commercial components that have been
processed and released or are currently in-progress in GPLM.
Phase 1 Benefits Implementing standardized and automation-assisted item processing and transfer of master data
to downstream manufacturing systems has resulted in the following benefits.
• Reduced the commercial item request-to-approval cycle time
• Eliminated more than 256 paper documents
• Automated flow of data to ERP, GVault and IQS has replaced manual transcription
• Digitally linking 264 part numbers to suppliers has significantly simplified and accelerated the review process
SIGNIFICANT BUSINESS BENEFITS
Enhanced CFR Part 11 compliant system, coupled with easier access to information, positively impacts audits and reduces compliance risk
An integrated, single, global system where all Items, BoMs, Supplier information, documentation, approvals & history captured for both Commercial and Clinical
Completely automated process to improve speed-to-market and manage increasing volume
Enhanced efficiency, productivity and integrity of data
Workflow-enabled processes that allow for real-time visibility to change history
Reduced cycle time due to improved efficiency, agility and greater visibility to product status
Streamlined Clinical Items Process review and approval
Single Source of Truth for all Clinical and Commercial Items
Session ID:
Remember to complete your evaluation for this session within the app!