FOCAL Application Overview

1. FOCAL Application Overview

2. FOCAL Software has extensive experience in developing and implementing electronic Quality Management systems for health services and life science since 1993. Owners: Founders (32%) TM Software (32%) Nyherji – IBM Iceland (24%) KB-Bank of Iceland (12%) FOCAL Software – Corporate Profile

3. FOCAL Software • Has installed over 20 000 user licences • Started working in quality mangement in 1993 • Started working in health care industry in 1996 • Has 90% market share in quality management systems in Iceland • Has 100% market share in quality systems for the health care sector

4. A few references • SWEDAC – Sweden • Electrolux/Husqvarna – Sweden, Finland • Norchip – Norway • GlaxoSmithKline • Reykjavik University Hospital • Össur – Iceland, Holland, USA, Sweden • Medicines Control Agency • Reykjavik Bloodbank • Lýf - biopharmaceutical • ...

5. FOCAL Quality Goals • Use modern technology to increasequalityof products and services • Support international standards and requirements • Simplify documentation, registration and assurance in quality processes • Make statistics, traceability and monitoring of quality processes a daily task • Support continuous improvement

6. Motives in health services • External: Improve life, health and safety of patients and health services staff • Internal: Improve your internal business process: • Lowered cost of data collection • Increased accuracy of data • Increased abilities in data analysis • Reduction in regulatory errors (for ex, eliminating misfilings) • Improved control over production, quality and other processes • More rapid search of electronic records • Improved informations transfer between companies (for ex – an external research organization and the sponsoring enterprise) • Improved product recall

7. Compliance – risk or cost saving? • The one time cost includes implementation, training, acquistion of any equipment or software involved and validation. • BUT: • On-going cost includes personnel cost, on-going traing and maintences of any hardware and software utilized etc • It also include the continuing effort to keep the compliance system in synch with evolving Standard Operating Procedures (SOPs) • However: • There are two ways of that the ease with which the computer component can be altered has a major impact. The first is the cost of the effort itself – does a change take a day, a week, or several moths of effort? The second, and perhaps more important, impact is the time lag between the decision to change the SOPs and the system being ready to support the changed SOP. If this lag is significant, it can serious impact your ability to improve operations.

8. With FOCAL Software:

9. Where do requirements come from? • Standards • Law and regulation

10. Law and regulation • 21CFR Part 820 Quality System Regulation (GMP) • Directive 98/79/EC on in vitro diagnostic medical devices • 21CFR Part 11 Electronic records and signatures • (not a complete list)

11. International standards • ISO 9001:2000 Quality management systems - requirements • ISO 13485:2000 Quality systems – Medical devices Particular requirements for the application of ISO 9001 • ISO 14971:2000 Medical devices – Application of risk management to medical devices • ISO 15489:2001 Records management

12. International standards • ISO 17025:2000 Quality systems – General requirements for the competence of testing and calibration laboratories. • EU-Directive 2002/98/EC – Quality and safety for the collection testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC • PIC/S GMP Guide for blood establishments • (not a complete list)

13. A few examples of how FOCAL fulfills requirements

14. Traceability Improvement Non- conformities QualityManual Capability Audits Projects Security Training Planning Control Verkefnis-stjórnun Reykjavik Bloodbank Model

15. FOCAL Application Overview

16. FOCAL Quality Management overview

17. Quality Manual System • Document management for quality documents • Policies, procedures, instructions, forms • Management process for quality documents • Editing, approving, publishing, revising • Electronic access to quality documents • Lotus Notes client, Internet, intranet, extranet

18. FOCAL Qualty Manual System Document database for quality documents, contaings processes for editing, approving and publishing documents with hyperlinks, process charts, electronic signatures e.t.c.

19. FOCAL Qualty Manual System Quality documents can be edited using popular word processing systems, or the built-in editor. Documents can include hyperlinks to other documents, URL’s or direct references to standards or other requirements.. FOCAL Software

20. FOCAL Qualty Manual System Work flow diagrams can be created with popular MS Visio or any other application and included, with hyperlinks. Click on one box and jump directly to another documnent.

21. FOCAL Qualty Manual System Documents can be published internally or externally and be read with a Lotus Notes client or Internet Browser . Hyperlinks work both ways. FOCAL Groupware

22. FOCAL Nonconformities and Complaints • Diverse forms for nonconformities and customer complaints • Process and follow up • Cost, trends, problem areas

23. FOCAL Nonconformities and customer complaints Register your production or service related nonconformitiesand customern complaints into this application and get total cost, trends and find problem areas. Also define and follow up on corrective actions.

24. FOCAL Internal and external audits Plan, schedule and execute Audits using this FOCAL module. Register all nonconformities and send to Corrective and preventive action.

25. FOCAL Human Resources All documents, personal and professional information are maintained in this comprehensive applicatinon. Status, training, previous jobs, CV, holiday planning, sickleave and other leave of absence, contracts e.t.c.

26. FOCAL Human resources – Employee evaluation Personal development, subjective and objective targets, personal interviews and follow up

27. FOCAL Customer Relations Management • Know your customers • Correspondance • Direct mailing • Sales Processes (i.e. “Solution Selling”) • Projects with customer involvement • Meeting management

28. FOCAL DOC+ CRM, Contact management, Project management, Meeting management and Records management. Used by Engineering, Utilities , Travel, ...

29. Research and development • Planning • Stages • Responsibilities and authorities • Design inputs and outputs • Review • Verification and validation • Control of design and development changes

30. FOCAL DOC+ R&D, Project Management, Work processes, Group work, Responsibility...

31. Measurement, analysis and improvement • Monitoring and measurement • Customer satisfaction • Audits • Nonconformities • Analysis of data • Continual improvement • Corrective action • Preventive action

32. Mynd af grafík FOCAL Statistics Creates tables and charts from all FOCAL applications and stores or sends with e-mail. Ad-hoc requests are also possible. Easy setup with MS Excel

33. Special requirements for medical devices • Verification and traceability of research, measurements and results • Risk management • Employee skills • Clinical evaluation in design process • Device retention period • Software used in research, development and production • Registering and handling nonconformities

34. Mynd af FOCAL Tækjaskrá FOCAL Equipment Inventory Maintains equipment inventory, calibration, maintenance, warranties, cost, break-down tracking, depreciation, cost e.t.c. for quality management, insurance and financial purposes