Quality System Overview Version Nov 2012 Alfred Medical Research & Education Precinct (AMREP) Austin Hospital © Copyright Nucleus Network 2012

Structure & Quality Policy Nucleus Network Quality System Overview Version 20-Jan-2009 Copyright Nucleus Network © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Business Operational Principles We have adopted two key business operational principles that are applied to all organisational processes and activities Project Management –As the process of combining resources, systems, processes, and people to complete a project to meet the established goals within the constraints of time, cost and quality Risk Management –As a process for the identification and management of significant risks –Supporting a scientific and practical approach to our decision-making process –Adopted AS/NZS 31000:2009 Risk management – principles and guidelines as the standard framework © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Niv 2012

Management Leadership  Management Leadership through Customer Focus, Planning, Resource Management and Management Review processes –Quality System Steering Committee (QSSC) Comprises of Senior Management QSSC Purpose; –Provide leadership in regards to the effectiveness of the Quality System –Conduct Management Review –Prioritise and facilitate Continuous Improvement/CAPA Management –Monitor Internal and External Audits © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Product Realisation Product Nucleus Network includes;  Clinical Trial Realisation  Consulting Services © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Facilities, Equipment, Materials & Services Clinical Trial Realisation © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Supporting Trial Realisation; Facilities & Equipment Policy  Validation Master Plan – F&E –Defines Calibration, Validation and Preventive Maintenance requirements for all equipment  Asset Register –All critical equipment listed  F&E Group exists to oversee this process Facilities & Equipment (F&E) © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Our support systems that ensure effective Product Realisation  Document Management  Information Management  Learning & Development  Change Control  Vendor Assurance Support Systems © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Document Management Nucleus Network Quality System Overview Version 20-Jan-2009 Copyright Nucleus Network Document Distribution and Control  Controlled copies of all Policies & SOPs are available in separate physical document libraries throughout each facility  All official controlled copies printed on blue paper  SOPs and forms are also made available online (Intranet)  Online SOPs are scanned versions of the signed master  Master documents are locked away under control of the Quality Department © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

ALCOATBDNC Documentation Standards © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Information & Communication Technology Policy  Validation Master Plan – GxP IT Systems –Back-Up Procedure Information Technology © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Learning & Development Policy  Learning & Development Group – Drives the L&D process – Monitors and tracks L&D achievements  All new employees attend; – Corporate Induction – L&D Handbook Training session Employee L&D Lifecycle Enables each employee to facilitate own training Learning & Development (L&D) © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Staff L&D Training Matrix Requirements All requirements are assessed for each position type; Mandatory Desirable Not Required Tracks status for each staff member; Trained/Met Gap Each employee has own individuals views of the matrix © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Commitment to Good Clinical Practice (GCP) Education of our employees  All staff are provided GCP Training as part of Nucleus Network Induction upon commencement  In addition, all permanent employees attend a minimum of a 2 day Good Clinical Practice GCP Education & Training © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Vendor Assurance Program –Classification of each vendor based on risk –Approved Vendor List –Strong relationships with key vendors e.g. Clinical Trial Pharmacy Hospital Pathology BioMedical Engineering Recall Australia (Archiving) Vendor Assurance © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Continuous Improvement of our systems and Product Realisation processes is a key focus of the organisation Measurement, Analysis and Improvement activities include; –Internal Audit Program –Corrective & Preventive Actions (CAPA) Management –GCP Quality Control –Key Performance Indicator monitoring Measurement, Analysis & Improvement © Copyright Nucleus Network 2012Nucleus Network Quality System Overview Version Nov 2012

Centre for Clinical Studies Austin Centre for Clinical Studies AMREP Alfred Medical Research and Education Precinct © Copyright Nucleus Network 2012 Nucleus Network Quality System Overview Version Nov 2012