1. Exmouth House 3–11 Pine Street London EC1R 0JH T +44 20 7832 5850 F +44 20 7832 5853 E office@adelard.com W www.adelard.com PT/227/30028/1 Extending ASCE: QMS and Technical file management ASCE User Forum Nick Chozos 04 June, 2015

2. © ADELARD Slide 2 INTRODUCTION ASCE Safety Cases Fault Trees Why-Because Analysis Bow-tie Analysis Project Management …. You will have seen the Adelard schema editor

3. © ADELARD Slide 3

4. © ADELARD ASCE key features ASCE is a versatile, flexible, customisable tool: Graphical environment Narrative behind graphical environment Information management and linking to diverse types of evidence Analysis within network and linked sources Reports ASCE can be integrated with other tools and corporate infrastructures, systems and procedures, in a light-weight, low- overhead manner Slide 4

5. © ADELARD Two example schemas Quality Management System A simple notation for designing and communicating QMS procedures within an organization, achieving compliance with ISO 14971, ISO 13845 and other QA standards. Technical File A tool for managing the process of technical file submission, including clause-by-clause compliance, tracking document changes, and the product assurance case. Slide 5

6. © ADELARD Quality Management System (QMS) Stakeholder requirements: QA team –Compliance with standards –Communication of procedures –Project templates (development, project lifecycles etc) Projects using QMS –Using templates and procedures Senior management –High-level view –Performance against QMS Internal auditors External auditors Supply chain Customers Slide 6

7. © ADELARD Quality Management System (QMS) QMS schema layers: Policy Project Operational / data analysis Policy Context / organizational information (structure, hierarchy) Regulation (clause-by-clause compliance) Slide 7

8. © ADELARD Quality Management System (QMS) Project Activities –Business process (e.g. procurement, contracts, invoicing..) –Project guidance (product or service: project management, development, assurance case….) –Assurance (internal reviews and audits, etc) Records Risks Operational Metrics Reports and dashboards (e.g. using databases through ASCE) Views (portable, e.g. html export) Slide 8

9. © ADELARD DEMO Slide 9

10. © ADELARD Medical devices sector FDA requires assurance cases for new (or modified) infusion pumps Slide 10 An infusion pump infuses fluids, medication or nutrients into a patient's circulatory system It is generally used intravenously, although subcutaneous, arterial and epidural infusions are occasionally used Infusion pumps are used in the hospital or at home

11. © ADELARD Medical devices sector Medical device manufacturers: ASCE Training on assurance cases and ASCE Consulting: –Risk management –Assurance cases –Technical file review (document submission to regulator) Slide 11

12. © ADELARD Technical files (multiple interlinked documents, 1,000s of pages) Slide 12

13. © ADELARD Technical file schema Technical file schema to manage process of 510k submission Regulatory compliance: A clause-by-clause compliance management tool Technical file: Used to manage the hierarchy of documents that make up the technical file, so that the evolution of documents can be tracked and recorded Assurance case: The typical Claims-Arguments-Evidence notation is also included, in cases where the manufacturer is required to, or wishes to produce an assurance case for their device Project management: Aspects of the schema to identify task/component owner, review status etc. Slide 13

14. © ADELARD Managing regulatory compliance in the technical file schema Slide 14

15. © ADELARD Managing document structure Slide 15

16. © ADELARD Project management Slide 16

17. © ADELARD DEMO Slide 17

18. © ADELARD Conclusion ASCE as an information management, customisable tool QMS schema Technical file schema Schemas are available upon request Slide 18

19. © ADELARD Slide 19