1. | Building the Effective Enterprise Benefits of Automating Quality Management Systems in Life Sciences Dave Medina Vice President – Life Sciences QAD, Inc.

2. | Building the Effective Enterprise 2 The following is intended to outline QAD’s general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, functional capabilities, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functional capabilities described for QAD’s products remains at the sole discretion of QAD. Disclaimer Benefits of Automating Quality Management Systems in Life Sciences

3. | Building the Effective Enterprise 3 ■Why automate QMS processes? ■CEBOS in the life sciences ■CEBOS QMS customer experiences ■Vision: QAD and CEBOS integration ■Summary Agenda Benefits of Automating Quality Management Systems in Life Sciences

4. | Building the Effective Enterprise 4 ■The benefits of automating QMS and integrating with QAD Enterprise Applications ■Combining QAD and CEBOS helps build the Effective Enterprise by:  Providing enterprise-wide visibility into quality system management processes  Connecting manufacturing and quality processes  Ensuring workflow and process consistency Session Overview Benefits of Automating Quality Management Systems in Life Sciences

5. | Building the Effective Enterprise 5 An Effective Enterprise in Life Sciences is: Benefits of Automating Quality Management Systems in Life Sciences Manufactures safe and effective products for patient care Patient- Focused Complies with applicable global regulations and requirements Compliant Innovates to improve all aspects of their operations Innovative Every business process working at peak efficiency and perfectly aligned with your strategic goals

6. | Building the Effective Enterprise Automating the Life Sciences Quality Management System Benefits of Automating Quality Management Systems in Life Sciences

7. | Building the Effective Enterprise 7 ■Homegrown, paper or departmentalized point solutions fail to…  …offer centralized view of quality and compliance  …integrate with enterprise systems to aggregate data  …connect to manufacturing processes  …easily adapt to changed compliance requirements  …ensure workflow and process consistency Why Automate QMS Processes? Benefits of Automating Quality Management Systems in Life Sciences

8. | Building the Effective Enterprise 8 ■Improve quality and compliance  Increase visibility into improvements, trends and risks  Standardize processes and workflow  Automatically collect quality data  Quality visibility across value chain  Interoperability with ERP Why Automate QMS Processes? Benefits of Automating Quality Management Systems in Life Sciences

9. | Building the Effective Enterprise 9 ■Improve products  Foster best-practice quality through automation of quality processes  Build compliance into processes  Implement continuous improvement by leveraging quality data Why Automate QMS Processes? Benefits of Automating Quality Management Systems in Life Sciences

10. | Building the Effective Enterprise 10 ■Reduce cycle times and resources  Streamlined workflow  Synchronize quality and manufacturing  Manage partners and suppliers −Monitor quality and compliance performance Why Automate QMS Processes? Benefits of Automating Quality Management Systems in Life Sciences

11. | Building the Effective Enterprise 11 ■Improve compliance  Integrate quality workflows into business processes  Consistent enterprise-wide quality processes  Visibility across supply chain −Enhance quality and compliance governance Why Automate QMS Processes? Benefits of Automating Quality Management Systems in Life Sciences

12. | Building the Effective Enterprise CEBOS in the Life Sciences Benefits of Automating Quality Management Systems in Life Sciences

13. | Building the Effective Enterprise 13 Life Sciences Solution Benefits of Automating Quality Management Systems in Life Sciences Document Control Device Master CAPA / NCR Complaint Handling Audit Mgmt. Training Mgmt. Calibration Risk Mgmt./ ISO 14971 Supplier Mgmt. QAD Enterprise Applications ISO 13485 GxP 21 CFR 11 Validation Powerful Integration ISO 14971

14. | Building the Effective Enterprise 14 Document Control Benefits of Automating Quality Management Systems in Life Sciences ■Version Management Single source of truth ■Change control Robust workflow Link to Training Tracking ■Secure Controlled Access ■Accessible Easy search and organization Document Control Device Master CAPA / NCR Complain t Handling Audit Mgmt. Training Mgmt. Calibration Risk Mgmt./ ISO 14971 Supplier Mgmt.

15. | Building the Effective Enterprise 15 Device Master Benefits of Automating Quality Management Systems in Life Sciences ■Device Master Easily configurable ■Device History File Maintain and track device information ■Design History File Processes to track & store design verification and validation data Document Control Device Master CAPA / NCR Complain t Handling Audit Mgmt. Training Mgmt. Calibration Risk Mgmt./ ISO 14971 Supplier Mgmt.

16. | Building the Effective Enterprise 16 CAPA and Non-Conformance Benefits of Automating Quality Management Systems in Life Sciences ■Corrective actions Automated management Trend analysis support MedWatch form 3500A ■Preventive actions Verify and document improvement actions Links to Risk Management ■Nonconformance Simple data entry with escalation as necessary Document Control Device Master CAPA & NCR Complain t Handling Audit Mgmt. Training Mgmt. Calibration Risk Mgmt./ ISO 14971 Supplier Mgmt.

17. | Building the Effective Enterprise 17 Complaint Handling Benefits of Automating Quality Management Systems in Life Sciences ■Complaint management Automated management Trend analysis support MedWatch form 3500A ■Corrective actions Configurable workflow Enforces a disciplined problem solving approach ■Preventative actions Verify and document improvement actions Document Control Device Master CAPA / NCR Complaint Handling Audit Mgmt. Training Mgmt. Calibratio n Risk Mgmt./ ISO 14971 Supplier Mgmt.

18. | Building the Effective Enterprise 18 Audit Management Benefits of Automating Quality Management Systems in Life Sciences ■Compliance Audit-based compliance approach support Ensure best practices ■Improved reporting Highlight areas requiring improvement Graphic, summary or detail ■Organized Automated management of audit function Document Control Device Master CAPA / NCR Complain t Handling Audit Mgmt. Training Mgmt. Calibration Risk Mgmt./ ISO 14971 Supplier Mgmt.

19. | Building the Effective Enterprise 19 Training Management Benefits of Automating Quality Management Systems in Life Sciences ■Qualification Management Qualified and current Cost-effective training ■Employee tracking Central repository and management system Manage everything related to employee training Document Control Device Master CAPA / NCR Complain t Handling Audit Mgmt. Training Mgmt. Calibration Risk Mgmt./ ISO 14971 Supplier Mgmt.

20. | Building the Effective Enterprise 20 Calibration Benefits of Automating Quality Management Systems in Life Sciences ■Calibration Management Optimized scheduling Electronic approval Disciplined tracking and maintenance ■Increased Effectiveness Status and trending analysis Automated workflow management Document Control Device Master CAPA / NCR Complain t Handling Audit Mgmt. Training Mgmt. Calibration Risk Mgmt./ ISO 14971 Supplier Mgmt.

21. | Building the Effective Enterprise 21 Risk Management / ISO 14971 Benefits of Automating Quality Management Systems in Life Sciences ■Failure Mode Effect Analysis Configurable FMEA tracking Uniform method for determining risk ■Organized risk management Risks grouped and analyzed using common criteria Links to documents, projects, and continuous improvement items Document Control Device Master CAPA / NCR Complaint Handling Audit Mgmt. Training Mgmt. Calibration Risk Mgmt./ ISO 14971 Supplier Mgmt.

22. | Building the Effective Enterprise 22 Supplier Management Benefits of Automating Quality Management Systems in Life Sciences ■Supplier performance Approved supplier list On-time delivery, PPM and additional metrics tracking ■Improved communication Corrective action response Access to latest documents and specifications Document Control Device Master CAPA / NCR Complain t Handling Audit Mgmt. Training Mgmt. Calibration APQP/Ris k Mgmt. Supplier Mgmt.

23. | Building the Effective Enterprise CEBOS QMS customers Life Sciences Compliance and Standards

24. | Building the Effective Enterprise 24 CORPAK Med Systems Benefits of Automating Quality Management Systems in Life Sciences Customer ProfileChallengesSolution U.S. medical device manufacturer of enteral products (Nasogastric (“NG”) feeding tubes, gastrostomy feeding tubes & enteral feeding safety devices Products distributed globally (U.S., Europe, Asia, Latin America) Recent acquisitions in the U.S. and UK Old home grown and internally applications that were expensive to improve and maintain No integration of applications or data CEBOS CAPA for Customer Complaints SCARs with electronic approval, & routing CEBOS Gage for calibration Documents to manage revisions, approval routing, and control. Paperless training management system Audit management module with CAPA integration

25. | Building the Effective Enterprise 25 X-Gen Pharmaceuticals Benefits of Automating Quality Management Systems in Life Sciences Customer ProfileChallengesSolution U.S. based manufacturer of mature generic pharmaceuticals Products include injectables, inhalents, oral, topical and specialty pharmacueticals CAPA managed using Excel Access files for quality data No automated workflow routing Poor visibility into quality trends CEBOS CAPA Module for CAPA mgmt Workflow, notifications, routing is automatic Easy visibility to status by all More robust security model Used CEBOS built-in reports and charts for trending

26. | Building the Effective Enterprise 26 Tecomet Benefits of Automating Quality Management Systems in Life Sciences Customer ProfileChallengesSolution U.S. based supplier of critical components for medical implants Serves markets in orthopedic, trauma, extremities, radiology, dental, spine, CMF and cardiovascular Compliance with ISO 13485 (GMP for medical devices) Inadequate document revisioning and control Training not integrated with document changes Tight integration with medical device manufacturer supply chain CEBOS Documents: ­Automatic retention ­Revision approval routing and history ­Release control Training Management : ­Triggers training when when documents go through significant revision changes ­Manage training planning and training history

27. | Building the Effective Enterprise Vision: QAD and CEBOS integration Benefits of Automating Quality Management Systems in Life Sciences

28. | Building the Effective Enterprise Drug Recall Benefits of Automating Quality Management Systems in Life Sciences FDA First Alert Distributor Pharmacy Class I Recall FDA Alerts Public Manufacturer Data Capture for Recall Effectiveness

29. | Building the Effective Enterprise Integrated Recall and CAPA Data Benefits of Automating Quality Management Systems in Life Sciences Complaint Manufacturer Data for CAPA QAD Data QAD Data Supplier Lot Trace – Back Supply Chain Partners Lot Trace – Forward

30. | Building the Effective Enterprise Recall: ERP and CAPA Integration Benefits of Automating Quality Management Systems in Life Sciences FDA Effectiveness Check CAPA Investigation Action Data from QAD Verification & Documentation

31. | Building the Effective Enterprise Integration for Quality Management Benefits of Automating Quality Management Systems in Life Sciences QAD Enterprise Applications Quality Management Software Supplier data Lot/product data Product QC data Quality trend data Change control Other ERP data For quality mgmt

32. | Building the Effective Enterprise 32 Summary Benefits of Automating Quality Management Systems in Life Sciences

33. | Building the Effective Enterprise 33 ■Integrating QAD with CEBOS QMS… ■…Improves quality and compliance ■…Improves products ■…Reduces cycle times and resources QAD & CEBOS Integration Benefits of Automating Quality Management Systems in Life Sciences

34. | Building the Effective Enterprise 34 ■Dave Medina, Vice President, Life Sciences QAD, Inc. d6m@qad.com Questions & Answers Benefits of Automating Quality Management Systems in Life Sciences

35. | Building the Effective Enterprise 35 ■Attend these related sessions:  Managing Quality and Compliance  Conquering Serialized Inventory Management ■Stop by the Solutions Expo ■Contact your QAD representative Next Steps Full Session Title

36. | Building the Effective Enterprise www.qad.com ©QAD Inc. 2013 36