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Unify quality manufacturing to drive speed, compliance and collaboration

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Veeva Systems
Veeva Systems

Whether you are an emerging CDMO looking to scale and attract sponsors or an established generics org looking to transform legacy systems, there is an approach to consider! Learn how you can drive efficiency, collaboration, and compliance and how to get started in unifying your quality manufacturing processes.

Technology
1 of 25
Glen DeGuzman Director, Vault Quality Strategy Solution Consultant, Vault Quality Ashley Wentworth
3 Copyright © Veeva Systems 2021 Industry trends and drivers for unifying quality systems Opportunities to unify quality processes Demo How to start unifying quality Q&A Agenda
4 Copyright © Veeva Systems 2021 Vision Building the Industry Cloud for Life Sciences Value s Do the Right Thing Customer Success Employee Success Speed A Public Benefit Corporation
5 Copyright © Veeva Systems 2021 Fastest Growing Company #2 Future 50 Company #8 Fastest Growing Public Tech Company A Public Benefit Corporation Founded 2007 • 950+ customers • 4,800+ employees • $1.5B+ revenue Global company, San Francisco Bay Area headquarters Cloud software, data, services, and consulting for life sciences
6 Copyright © Veeva Systems 2021 The Industry Has Changed Globalization & Externalization • Quality processes extended to partners, yet systems are only internally accessible • Lack of global visibility across internal and external quality Increasing Complexity • Biosimilars, combination products, and non-biological complex drugs are more involved to manufacture • Continued M&A activity challenges systems and processes More Regulations, Complex Enforcement • Meeting new and changing regulations is onerous • Compliance is complex and impacts agility
7 Copyright © Veeva Systems 2021 Drivers for Unifying Quality Systems Agile Digital Systems in Quality Connected end-to-end processes Third party collaboration within quality systems Shift toward proactive quality
8 Copyright © Veeva Systems 2021 Opportunities for Unifying Quality 1 Unifying internal quality processes. Unifying across external partners. 4
Unifying and Connecting Quality Streamlining business processes within quality and across business functions
10 Copyright © Veeva Systems 2021 Unify Quality Management Applications QMS Elements Interconnections Unification of multiple disparate quality applications onto a single platform All QMS elements unified with standardized processes and data model Interconnections between applications are standardized and maintained
11 Copyright © Veeva Systems 2021 Unifying Quality Across Applications Quality Event CAPA Change Control Better Intelligence Seamless Process Accurate Product Releases Qualify by Role QMS Implementation Actions Document Change Control Automated Re-Training
12 Copyright © Veeva Systems 2021 Content Updates Fully Unified into Change Process • Eliminate multiple systems and complex integrations • End-to-end workflow visibility and automation • Documents can be grouped by common authors and reviewers, grouped into role-based curricula, and associated with one or more change actions • “Just-in-time training” to optimize compliance readiness Document(s) Change Action Change Request Change Actions Completion Impact Assessment Change Plan Creation Pre-Approval Post Approval Coordinated Change/Doc Release Closure Auto Re-training Triggered Qualification Verification
13 Copyright © Veeva Systems 2021 Quality Risk Management Risk Lifecycle Workflow to Enable Transparency and Collaboration Operational Risk Register Risk 1 (Score 100) Risk 2 (Score 30) Mitigation Actions Mitigation Actions Supplier Risk Register Risk 1 (Score 80) Mitigation Actions Closed RISK LIFECYCLE WORKFLOW Residual Risk Risk Treatment Evaluate Analyze Identify
14 Copyright © Veeva Systems 2021 ERP Integration ERP QMS Place batch restrictions Update and/or batch restrictions Quality Event Initiation Triage & Impact Assessment Investigation & Disposition CAPA Planning & Execution Traceability to Change Control Batch/Lot/Material/ Equipment Lookup and Association
Improving Third-party Collaboration Bringing Suppliers, Partners, and Customers within Quality Systems
16 Copyright © Veeva Systems 2021 Providing Access to Suppliers, Partners, and Customers Then and Now Purchase additional software products Attempt training external users on legacy systems Manage complex security Configure complex VPNs and firewalls Integrate additional products to legacy system Configure Security and Access Privileges Legacy Systems Modern Cloud X X X
17 Copyright © Veeva Systems 2021 Real-time Collaboration for Partners and Customers Direct access to documents and data Bidirectional workflows to manage approvals with customers Control access to information based on metadata Manage both remote and on-site audits Seamless findings and responses
18 Copyright © Veeva Systems 2021 Unified quality management
Demo
How to Get Started
21 Copyright © Veeva Systems 2021 Best Practices to Get Started Simplify and harmonize internal and external business processes Develop strong partnership between business and IT Pick the right vendors and partners with aligned culture and priorities Think long term, put actions in place to significantly move the needle 1 2 3 4
22 Copyright © Veeva Systems 2021 Summary Industry Changes Are Driving Transformation Many Opportunities to Unify Quality Deliver Value with Unified Solutions Designed for Life Sciences
23 Copyright © Veeva Systems 2021 How can we help? ashley.wentworth@veeva.com Ashley Wentworth Contact us: Learn more: veeva.com/quality Glen DeGuzman glen.deguzman@veeva.com
Questions Q&A
Thank you Q&A • veeva.com/quality

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Unify quality manufacturing to drive speed, compliance and collaboration

  • 1.
  • 2. Glen DeGuzman Director, Vault Quality Strategy Solution Consultant, Vault Quality Ashley Wentworth
  • 3. 3 Copyright © Veeva Systems 2021 Industry trends and drivers for unifying quality systems Opportunities to unify quality processes Demo How to start unifying quality Q&A Agenda
  • 4. 4 Copyright © Veeva Systems 2021 Vision Building the Industry Cloud for Life Sciences Value s Do the Right Thing Customer Success Employee Success Speed A Public Benefit Corporation
  • 5. 5 Copyright © Veeva Systems 2021 Fastest Growing Company #2 Future 50 Company #8 Fastest Growing Public Tech Company A Public Benefit Corporation Founded 2007 • 950+ customers • 4,800+ employees • $1.5B+ revenue Global company, San Francisco Bay Area headquarters Cloud software, data, services, and consulting for life sciences
  • 6. 6 Copyright © Veeva Systems 2021 The Industry Has Changed Globalization & Externalization • Quality processes extended to partners, yet systems are only internally accessible • Lack of global visibility across internal and external quality Increasing Complexity • Biosimilars, combination products, and non-biological complex drugs are more involved to manufacture • Continued M&A activity challenges systems and processes More Regulations, Complex Enforcement • Meeting new and changing regulations is onerous • Compliance is complex and impacts agility
  • 7. 7 Copyright © Veeva Systems 2021 Drivers for Unifying Quality Systems Agile Digital Systems in Quality Connected end-to-end processes Third party collaboration within quality systems Shift toward proactive quality
  • 8. 8 Copyright © Veeva Systems 2021 Opportunities for Unifying Quality 1 Unifying internal quality processes. Unifying across external partners. 4
  • 9. Unifying and Connecting Quality Streamlining business processes within quality and across business functions
  • 10. 10 Copyright © Veeva Systems 2021 Unify Quality Management Applications QMS Elements Interconnections Unification of multiple disparate quality applications onto a single platform All QMS elements unified with standardized processes and data model Interconnections between applications are standardized and maintained
  • 11. 11 Copyright © Veeva Systems 2021 Unifying Quality Across Applications Quality Event CAPA Change Control Better Intelligence Seamless Process Accurate Product Releases Qualify by Role QMS Implementation Actions Document Change Control Automated Re-Training
  • 12. 12 Copyright © Veeva Systems 2021 Content Updates Fully Unified into Change Process • Eliminate multiple systems and complex integrations • End-to-end workflow visibility and automation • Documents can be grouped by common authors and reviewers, grouped into role-based curricula, and associated with one or more change actions • “Just-in-time training” to optimize compliance readiness Document(s) Change Action Change Request Change Actions Completion Impact Assessment Change Plan Creation Pre-Approval Post Approval Coordinated Change/Doc Release Closure Auto Re-training Triggered Qualification Verification
  • 13. 13 Copyright © Veeva Systems 2021 Quality Risk Management Risk Lifecycle Workflow to Enable Transparency and Collaboration Operational Risk Register Risk 1 (Score 100) Risk 2 (Score 30) Mitigation Actions Mitigation Actions Supplier Risk Register Risk 1 (Score 80) Mitigation Actions Closed RISK LIFECYCLE WORKFLOW Residual Risk Risk Treatment Evaluate Analyze Identify
  • 14. 14 Copyright © Veeva Systems 2021 ERP Integration ERP QMS Place batch restrictions Update and/or batch restrictions Quality Event Initiation Triage & Impact Assessment Investigation & Disposition CAPA Planning & Execution Traceability to Change Control Batch/Lot/Material/ Equipment Lookup and Association
  • 15. Improving Third-party Collaboration Bringing Suppliers, Partners, and Customers within Quality Systems
  • 16. 16 Copyright © Veeva Systems 2021 Providing Access to Suppliers, Partners, and Customers Then and Now Purchase additional software products Attempt training external users on legacy systems Manage complex security Configure complex VPNs and firewalls Integrate additional products to legacy system Configure Security and Access Privileges Legacy Systems Modern Cloud X X X
  • 17. 17 Copyright © Veeva Systems 2021 Real-time Collaboration for Partners and Customers Direct access to documents and data Bidirectional workflows to manage approvals with customers Control access to information based on metadata Manage both remote and on-site audits Seamless findings and responses
  • 18. 18 Copyright © Veeva Systems 2021 Unified quality management
  • 19. Demo
  • 20. How to Get Started
  • 21. 21 Copyright © Veeva Systems 2021 Best Practices to Get Started Simplify and harmonize internal and external business processes Develop strong partnership between business and IT Pick the right vendors and partners with aligned culture and priorities Think long term, put actions in place to significantly move the needle 1 2 3 4
  • 22. 22 Copyright © Veeva Systems 2021 Summary Industry Changes Are Driving Transformation Many Opportunities to Unify Quality Deliver Value with Unified Solutions Designed for Life Sciences
  • 23. 23 Copyright © Veeva Systems 2021 How can we help? ashley.wentworth@veeva.com Ashley Wentworth Contact us: Learn more: veeva.com/quality Glen DeGuzman glen.deguzman@veeva.com