Qumas Collaboration to Innovation Quality QMS PIMS 2014 How Enterprise Quality Management can protect your customers, keep you compliant, and have a positive effect on your bottom line. www.pims.gb.com www.gbx.uk.com

1. Leveraging Compliance and Collaboration Strategies to
overcome pitfalls across the Manufacturing lifecycle:
Enhancing your collaboration maturity across sponsors and suppliers
Ken Hayward, CTO, QUMAS

2. 2
Proposition & Agenda
To gain competitive advantage, organizations must
establish a robust, enterprise-scale, mature collaboration
model for sharing critical information (in a way that meets
global regulatory requirements).
This session will outline why this is needed and how to
achieve collaboration maturity:
 Establishing a framework for compliant collaboration
 Recognizing the current challenges and problems
 Understanding technology innovations and current
availability
 Defining a path for compliant, collaborative engagement

3. 3
QUMAS at a Glance
 Capability
- Leader in Quality and Compliance Solutions to
Life Sciences since 1994
- High-Profile Customer Base in Leading
Pharmaceutical, Biotech and Medical Device
companies
- Analysts recognize QUMAS as a Compliance
Leader and Visionary
 Enterprise Scale
- Over 270 customer deployments
- Largest Client > 120,000 users on-premise
(smallest client 20 users in the Cloud)
- Systems with > 5,000,000 Documents
- Cross Department usage from preclinical to
manufacturing and supply chain
US HQ in Jersey City, New Jersey
Global HQ, Research & Development in
Cork, Ireland
Sales Offices in Boston, Jersey City,
Philadelphia, Atlanta, San Francisco,
London, Dublin, Munich, Singapore,
Paris
Global Services

4. 4
Big Changes in Ways of Working
ACME Pharma
Customers and
Patients
Supply Chain

5. 5
Big Changes in Ways of Working
ACME Pharma
Social Interaction with &
between Customers
Integrated Supply Chain
Big Data Analytics
Transition to
Cloud Platforms

6. 6
Where is the gap?
Expectations Operation Audit
• Internal systems cover the setting of expectations and
audit / close out of the operation
• You have limited visibility and control over the operation
itself
• Bridging the gap between responsibility and control is
becoming more critical as complexity and quantity of
partnerships increase

7. 7
Supply and Distribution Network
Primary
Market Approval
Holder
API
CMO
Excipients
Packaging /
Third Party
Logistics
4PL
Packaging /
Third Party
Logistics
Ingredients
Excipients
Excipients
Ingredients
Ingredients
API
CMO

8. 8
Supply and Distribution Network
Primary
Market Approval
Holder
API
CMO
Excipients
Packaging /
Third Party
Logistics
4PL
Packaging /
Third Party
Logistics
Ingredients
Excipients
Excipients
Ingredients
Ingredients
API
CMO
Scope of Product Quality Responsibility

9. 9
Gartner Survey

10. 10
Fragmented Systems

11. 11
Core Future Strategy
Implement systems to mediate and manage the deliverables of the
relationships in the context of an agreed, orchestrated process:
 Move from one to one relationships to one to many
 Implement automation and agreed processes
 Move content from internal to external systems
 Delegate specific authority to 3rd parties
 Move from Document Driven Processes to Data Driven
Processes

12. 12

13. 13
Future Strategy Model
Primary
Market
Approval
Holder
API
Excipients CMO
Packaging
/ 3pl
4PL
(Asia)
Ingredients
?

14. 14
Future Strategy Model
Primary
Market
Approval
Holder
API
Excipients CMO
Packaging
/ 3pl
SharePoint
Panel 2pm
4PL
(Asia)
Today
Ingredients

15. 15
What should be included?
 Documents
- The most obvious place to start is with Content
- Initial view would be for safe transfer of approved Documents
- Subsequently allowing for editing and review
- Ultimately leading to full scale exchange including withdrawals, training etc.
 Processes
- Ability to exchange automated Forms and Workflows
- Audit findings and responses would be a great starting point
- Deviations
- CAPA’S
- OOS’s
- Complaints etc.

16. 16
Who owns this problem?
Lack of clarity on ownership is part of the problem:
• QA?
• Regulatory Affairs?
• Operations?
• CIO?
All of the above and more…

17. 17
How do we make it easy?
Acknowledgement of the issue in a wider sense:
 Definition of Policy and approach across the company
 Acceptance of the need to address systems/processes
 Definition of overall requirements
 Apply an owner (of some standing)
 Begin to implement a longer term solution
 Audit for exposure, risk and correction

18. 18
How do we know it’s working?
There are some anticipated advantages to look for:
 Speed of updates between parties
 Ease of Audit
 More “Evidence”, less “Expectation”
 Faster adoption on projects, changes
 Real time visibility on CAPA’s, Deviations etc.
 More predictable Supply Chain

19. 19
Where is the strategic advantage?
 Ability to assess and compare various parties
 Far greater predictability on execution/delivery
 JV’s, Partnerships have system to support them
= Running Ecosystem is no different than own Company!
Enormous Benefits begin to accrue in terms of:
 Speed
 Trust
 Agility
 Certainty

20. 20
Collaborating Implies Access
 Actual implementation => Cloud?
 Connectivity:
 Cloud
 Firewalls
 Peer-to-peer
 Sponsors
 Shared Systems/users

21. 21
Summary
 Supply Chains are not getting any simpler and cost pressures remain
high
 We need to bridge the gap between expectation and evidence
 Connecting multiple 3rd parties through our firewalls is not workable
 Cloud based platforms allowing peer-peer relationships (flattening the
supply chain) allow us to reach 2nd and 3rd tier partners
 Compliance throughout this network can be achieved without raising
costs prohibitively

22. 22
Questions?
Thank you for your time today!
Contact us for more information & to arrange a detailed discussion.
 Free Phone US: 800 577 1545
 NJ, US: 973-805-8600
 Cork, Ireland: +353 (0)21 4915100
 info@qumas.com
 www.qumas.com
 Follow QUMAS