TrackWise - Quality Management System

TrackWise - Quality Management System Focus area: Electronic Management of CAPA Systems in the Regulated Industry May 11, 2007 Yaniv Vardi VP, Operations Sparta Systems Europe, Ltd.

Agenda Sparta Systems overview QMS Overview Holistic QMS/CAPA approach CAPA in QMS overview Typical challenges and how to address it QMS requirements QMS implementation methodology Q&A 2

Sparta Overview

Sparta Systems, Inc. Founded: 1994 The vision: Tracking needs are endless / span over all industries Off-the-shelf, 100% user configurable One vendor / one tool / responding to all needs Development of TrackWise First released in 1995 1998 Focus on FDA-regulated industries More than 150 FDA-regulated clients, 250,000 end users Passed over 60 customer audits + PDA Audit in 2001, 2003 and 2006 Regulatory awareness Financially Secure Profitable operations since 1994 Recognized revenues $14.4M in 2004, $24M 2005, $33M 2006 Equity partners with AIG Healthcare Partners and Summit. 4

Presence in the Regulated Industries Pharma Blood Services Generic Contract Mfg. Best Practices Biotech Medical Device NIAID Gov t / Other 5

QMS Overview

Quality Management Software Centralizes QMS areas into a single solution Provides global access (web-based, UTC compliant, Multilanguage) Ensures security at the organization and process level Assures control of GMP processes Provides information not just data (trending, reporting, etc.) Proactively alerts responsible parties when actions are required Integrates to key systems throughout the enterprise (ERP, MES, LIMS, CRM) Ensures flexibility to support changes as needed (when process changes are required 7

The TrackWise Solution Single vendor / single tool solution for all possible quality management compliance needs Highly modular, yet no modules required to implement any application TrackWise can be configured to address customer needs in all areas = Projects Off-the-shelf fully user configurable Configuration is accomplished using point-and-click tools, with no changes to source code Web-based user access Integration to key systems throughout the enterprise 8

The Need to manage compliance Compliance management needs are endless Change Control Deviations, Nonconformance Complaints, Customer Concerns Clinical Trial Management Investigations Corrective / Preventive actions (CAPA) Action Items Audits, Observations & Commitments Safety & Environmental Events Regulatory Commitments Supplier Quality Management Sarbanes-Oxley And much more 9

Trends in Quality Management System FDA attempting to harmonize and modernize GMPs Increased focus and re-definition of CAPA Risk Management to identify key areas that may be subject to great safety risks Increased regulatory enforcement Effectiveness checks Current best practices require tools to monitor, measure, and analyze the operations. 10

Holistic Approach to Quality Management Globalize (harmonize) around a common philosophy and approach Standardize definitions and processes at a corporate level ( Level II ) Provide flexibility for site level variations (Level III ) Use quality metrics as a basis for continuous improvements Trending Problem Analysis Thorough Investigations and Root Cause Analysis Ensuring CAPA effectiveness Bring attention to risk areas to prevent problems 11

Integrated QMS: Before and After Supplier Management Supplier Management Audits Safety Incidents Doc. Events Management Audits CAPA NCP Customer Inquiries Typical Quality Systems Relations Change Control Commitments Maintenance Safety Incidents CAPA EH&S Quality Management System efficient compliance Change Control Commitments Validation Management Supplier Management Asset Management NCP Assets Management Complaints Complaints 12

CAPA in QMS overview

Holistic QMS Defines CAPA Sources Supplier Audits Nonconformance Deviations Out of Specification Regulatory Audits Complaints Internal Inspections Out of Specification Adverse Trends Adverse Events Incoming Inspections And more Numerous source areas for Quality Related Issues Scope of problems that drive CAPAs go beyond nonconforming product Any process that affects product quality is included 14

CAPA & Change Management Drivers Out of Spec Complaints Patient Adverse Events Observations Lab Distributor Manufacturing CAPA & Change Management Packaging Packaging Regulatory Audits Deviations Manufacturing Supplier Audits Nonconformance Raw Material Audits Internal Audits 15

Deviation & CAPA Processes Regardless of where the problem originates, or what type it is, it must follow a process Metrics and Reporting Change Control Identify & Triage Investigate, Root Cause, Action Plan Review & Approve Plan Implement Actions Verify Effectiveness Identify problem Assess impact Quality / Regulatory / Management Notification Investigation Process? Complete Investigation Determine Root Cause Proposed Corrective / Preventive Actions Plan effectiveness Assess changes Ensure no impact to product quality Consensus from SMEs Approval Implement Actions Verify completed Inform stakeholders Measure to ensure problem has been resolved Monitor to ensure it is not re-occurring 16

System Overview 17

Typical Challenges

Typical Challenges Challenges in Problem Identification Missing view of the big picture Lack of ownership and accountability Inability to link related problems Insufficient tools for trending and analysis Challenges in Investigation Quality of investigations is poor Missing & incomplete information Inability to easily review similar past investigations Inconsistent investigation process & Root Cause Not determining root cause Past due investigations, not being closed, get lost Challenges in Planning Vague root cause analysis Confusion over what is corrective and what is preventive action Inability to relate corrective actions to source problems Lack of integration to Change Control System Problem Identification Identify & Investigate Root Cause Create Action Plan 19

Typical QMS Challenges (cont.) Challenges in Review & Approval Not sure who needs to approve Approvals in serial, not parallel Approval process takes long time Lack of key stakeholder input Challenges in Implementation No way to track issues through workflow Lack of visibility to open items Lack of visibility to related items Changes to plan mid-stream Compliance risk Challenges in Effectiveness Easy to forget to measure effectiveness Difficult to gather necessary metrics No means to generate metrics Inability to measure effectiveness does not give us any assurance if we are addressing the root cause of the problems Review & Approve Plan Implement Actions Verify Effectiveness 20

Addressing Challenges

Record the Event Capture all related data of any event regardless of the type Source Date & Time of Event Type Description Department For issues surrounding Events, utilize a quality evaluation: Quality Event only Quality Event + CAPA Quality Event + Investigation + CAPA + Change Control Log observations / trends to implement pro-active changes Use notifications and Dashboards to monitor outstanding Events 22

Perform Assessment & Investigation Assign Lead Investigator Use Push or Pull concept Assess impact, consider decision tree approach Create Investigation Plan Use Parent-Child concepts track each investigation task Business rules for proper task assignment Track & Complete Investigations Use workflow, due dates and reminders Escalation of past due investigations Search & Reporting User Dashboards Analyze Root Cause Structure Root cause Analysis Tree Use Root Cause to Drive CAPA process 23

CAPA Plan & Approval Review currently in progress CAPAs Create CAPAs and link to root cause If multiple CAPAs identify which ones resolve which root cause? Which actions must be closed to close the deviation? Create an Effectiveness Plan at this time Determine Approvers Use pre-set approver functions if possible Route Investigation & CAPA plan for approval Email alerts, reminders Dashboards Obtain Approval Ability to reject to various previous workflow states 24

Implementing CAPA & Effectiveness Each CAPA record should have its own record and workflow Use Parent-child relationships to break up the process into smaller bites Action Item Tracking Track completion and verification of each CAPA Use workflow, due dates and reminders Escalation of past due investigations Search & Reporting User Dashboards Measure effectiveness according to the plan -> evidence that root cause has been eliminated 25

Important QMS Requirements

High Level Requirements Defining the Requirements Centralized database Handles all process areas - modular Workflow driven Proactive user notification and escalation Action items management Querying & Reporting Elaborate security by user-group Management reports Performance Metrics & Trending Part 11 Compliance 27

QMS Implementation methodology

Implementation Methodology 4 weeks 6 weeks 8 weeks 1-2 weeks per site Post Release Requirements / Configuration Design Prototyping, Finalize Configuration, Documentation Validation / SOPs / Training Go Live! Deploy to additional sites TrackWise Orientation Project Kick-off User Workshops - review Preconfigured, gather requirements Establish plan for harmonization of selection list value Configuration Design Installation of Dev. Environment Configure Prototype 1 Initial Integration Design Project Team Workshop-1 Configure Prototype 2 User Requirements Finalization Project Team Workshop-2 Finalize Configuration Design Finalize harmonization items Reports Customization Train on Validation Templates Complete setup of integration tools Functional specifications Initial validation activities TrackWise Certification Training Install Production Execute and approve IQ Risk-based OQ (review already executed OQ from validation package) Execute and approve PQ Complete validation protocol Create Training Materials Revise SOPs Train Super Users Train Users Train Help Desk Roll out phase Support application Create site users Site level SOPs Training users at site Site PQ 29

Benefits Improved control and consistency through structured and validated data input and workflow Centralized CAPA process, by using a single, integrated system Reduced risk by eradicating any potential of missing records, missing data, or missed approvals Decreased product release cycle time by closing corrective and preventive actions faster Increased visibility by alerting users when work is required and escalating late issues 30

Q & A 31