Focus on Patient & Product Quality as the foundation for Data Integrity

Transcription

1 Focus on Patient & Product Quality as the foundation for Data Integrity Doreen Newhouse, Global Head, Sandoz Data Integrity Office presented by James Mann, Head Data Integrity Program Management, Pharma Barcelona, Oct 27, 2015

2 FDA Warning Letters about DI to Indian suppliers 2 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

3 EU regulators are taking strong action on DI 3 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

4 Data Integrity: what are we aiming for? Accurate Complete DATA Consistent Secure 4 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

5 Why is it so hard for companies to get it right?! Performance & business pressure Root Causes Lack of awareness or capability DI not fully integrated into Culture Inadequate processes & technology 5 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

6 Why is it so hard for companies to get it right?! Performance & business pressure Root Causes Lack of awareness or capability DI not fully integrated into Culture Inadequate processes & technology 6 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

7 Why is it so hard for companies to get it right?! Performance & business pressure Root Causes Lack of awareness or capability DI not fully integrated into Culture Inadequate processes & technology 7 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

8 Why is it so hard for companies to get it right?! Performance & business pressure Root Causes Lack of awareness or capability DI not fully integrated into Culture Inadequate processes & technology 8 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

9 Why is it so hard for companies to get it right?! Performance & business pressure Root Causes Lack of awareness or capability DI not fully integrated into Culture GUEST 1234 Inadequate processes & technology 9 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

10 Why is it so hard for companies to get it right?! Performance & business pressure <20% Intentional Root Causes Lack of awareness or capability DI not fully integrated into Culture >80% Unintentional Inadequate processes & technology Note: bias based on reporting 10 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

11 Four vital steps towards Data Integrity Education and Communication Detection and Mitigation of Risks Technology and IT Systems Governance of DI 11 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

12 Four vital steps towards Data Integrity Education and Communication Detection and Mitigation of Risks Technology and IT Systems Governance of DI 12 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

13 What education? What communication? How to recognize DI issues EDUCATE DI is everyone s responsibility COMMUNICATE 13 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

14 Examples of how we re communicating the risks...and related impact! 14 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

15 Culture and education is the foundation for a strong Data Integrity mindset Training Executive awareness course Foundational E-learning Auditors training Process & System owners Communication Why Data Integrity - story Educational video Microsite with toolkit Campaign material Change Mgt Data Integrity Learning Maps DI Quality Conversations Values & Behaviors Change Champion workshops BPO Training Training on fraud including a GxP example Data Integrity Definitions ALCOA Leaflet Data Integrity microsite Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

16 People are always an element of control......so mindset shift to strengthen understanding of Data Integrity and impact on patients safety and product quality are key. Education and consistent communication ensure: A common understanding Awareness of impact Ownership Leadership support Any further activities can now build on this to ensure sustainability! 16 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

17 Four vital steps towards Data Integrity Education and Communication Detection and Mitigation of Risks Technology and IT Systems Governance of DI 17 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

18 Understand risks: known risk areas Understand current risks Version control? Traceability? Access control? Archiving raw data? Audit trail? Segregation of duty? Access control? Accountability? Traceability? SPREADSHEETS STAND-ALONE INSECURE ID 18 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

19 DLCPM*: understand risks, optimize processes *Data Lifecycle Process Mapping Mitigate risks EXAMPLE 1??? Electronic data. Paper Printout. Improved data QA integrity reviews Greater efficiency & signs Less cost notebook. Less frustration Reduce size to fit notebook. Signature QA reviews notebook scanned electronic to PDF. data 19 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

20 Understand risks through DLCPM* *Data Lifecycle Process Mapping Mitigate risks Can we review original data? Do users (not just IT) understand data flow? Can users change or bias results? AVAILABILITY OWNERSHIP CONTROLS 20 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

21 Four vital steps towards Data Integrity Education and Communication Detection and Mitigation of Risks Technology and IT Systems Governance of DI 21 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

22 Processes & systems: prevent risks from emerging Mitigate risks Define minimum Requirements Define IT & Process Standards Implement Requirements EXAMPLE EXAMPLES EXAMPLE Create explicit requirements for all types of systems, including manual, automated/it and hybrids. Segregate duties so that those who generate data cannot change it. Require data storage & archiving. Lock down systems with individual logins, enable audit trails, apply the Four Eye principle. 22 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

23 Define IT and technology strategy Business Area Data Integrity IT Strategy What does our technology landscape vision look like? How far and fast do we want to move towards our vision? IT QA What are our options? What s practical? 23 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

24 Four vital steps towards Data Integrity Education and Communication Detection and Mitigation of Risks Technology and IT Systems Governance of DI 24 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

25 Establish governance structure Local Division DI Subject Matter Experts provide guidance, recommend improvements Local Division GLOBAL Division Local Define DI strategy and standards Monitor developments internally and externally Owners of business processes and systems 25 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

26 Establish holistic framework to address DI issues Detect Identify Learn Monitor What s the DI issue? What is the root cause? How will we fix it across the company? Is the fix effective? (Right trend?) INDIVIDUAL ISSUE HOLISTIC RESPONSE 26 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

27 Collaborate to leverage lessons learned Functions Accurate Regulators Complete DATA Consistent Divisions Secure Industry 27 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

28 Collaborate to leverage lessons learned Functions Internal Accurate Regulators Complete DATA Consistent Divisions Secure Industry 28 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

29 Learn lessons from the industry and regulators Functions Accurate Regulators Complete DATA Consistent Divisions External Secure Industry 29 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

30 As awareness rises, we ll see more issues at first Number of DI Issues Awareness Action Maintenance Near-term Long-term 30 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

31 Priorities: patient and product quality Data about safety and efficacy PATIENT Data that ensures product quality PRODUCT 31 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only

32 Discussion How are you prioritizing your DI initiative / activities? Where have you chosen to start? Why? 32 Data Integrity, A Novartis Approach Pharma Process Barcelona 27 October D.Newhouse/J.Mann Business Use Only