IVT 2017 Validation Week Europe

Transcription

1 Educational Workshop Agenda IVT 2017 Validation Week Europe 5 Steps to Plan, Justify & Implement e-validation & Taking Your IDEA/VISION to the Finish Line Global BioPharma e-validation Case Study

2 Background LifeScience Industry Career Experience Introduction: Lou Killian Abbott: QA, QC, Operations, Engineering, Regulatory, Qual Systems, Compliance, Global Doc Program, Val Genentech: QA, QC, Enterprise Quality Systems, Document Management, Validation BioMarin: Enterprise Business Systems, Validation, Compliance Preparedness, Data Integrity Consulting EXPI=Excellence in Productivity Improvement Kneat e-val Solution- Customer Success and Education Career Passions Understand and Define Best Business Processes Apply Technology to Address Business Process Pain Points Implement User-friendly and Functional Systems (establish the most effective business process not just a tool) Productivity & Compliance Assurance Improvements

3 Background Professional Engineer with Focus on CQV Experience Introduction: Rick Mineo Biogen: CQV Consultant Implementation of e-lms system, Sterilization Program Development. Baxalta: CQV Manager $1B Greenfield Project Grifols: RV/IV Manager $400M Facility Expansion Wyeth: ICV Area Manager $2B Green Field Project Career Passions Engineering Quality Design through Final Form Work Process Optimization Innovation

4 Questions for Audience 1. How many people are involved in supporting Validation activities? 2. What types of validations do you support? Equipment, Facilities, Process, Cleaning, Computer Systems, Methods? 3. How many people are in companies considering a Paperless e-validation Solution? 4. How many people can relate to the following list of Validation Business Process Challenges? Typical Validation Business Process Pain Points/ Challenges High level of effort/ time to Create, Execute and Maintain Validation records Cross organization/cross sites inconsistencies No real time viewability of Val Index, Val Status and Val Records No standardized Val Process and Templates/ Workflows across projects/sites No efficient process to leverage previous Val information for current tasks Accurate Metrics not available Inefficient Val Record Management, Storage and Retrieval Data Integrity concerns i.e. ALCOA principles

5 Traditional Validation LifeCycle Management is Paper based...

6 Paper Pete!

7 Traditional Paper Based Review/Approval Process Paper Pete!

8

9 Paper Pete! Efficient Eddie!

10 Validation Process Pain Points/Challenges Productivity, Efficiency & Speed High effort to Create and Manage Validation Records Time consuming Review, Approval, Execution cycles Validation Process Alignment & Control Real time Metrics not instantly available No standard Validation process & records format Information Access & Data Integrity Poor Record management, storage and retrieval Data Integrity; ALCOA principle Supporting Company Growth Extend and Standardize across new products/sites Validation Compliance Ever increasing levels of Regulation (FDA) Knowledge Transfer Access to the right information quickly Share Val Data across sites

11 Addressing The Val Process Pain Points /Challenges GOALS Productivity Productivity Productivity Information Access Alignment Company Growth Compliance Traditional Val Process Pain Points: High level of Effort & Time to Create/Maintain Validation Records & Assess Change Impact Inefficient process for Records Review/Approval, Val Test Execution & Deviation Management Inefficient Val Record Management, Storage and Retrieval No real time viewability of Val Index, Val Status and Val Records Val Process & Records not Aligned & Extendable across business areas, projects and sites No efficient process to leverage previous Val information for current Val tasks Compliance Risks & Data Integrity concerns (i.e. ALCOA principles) E-Val Process Improvements Efficient and Compliant Val Records Creation, Maintenance & Change Control Efficient and Compliant Records Review/ Approval, On-line Test Execution & Deviation Management Efficient and Compliant Val Records e-management, Storage & Retrieval Instant web access to all Records, Data & Metrics Real Time Val Index & Val Status Dashboard E-Val process provides extendable standardized functionality across company and new sites E-val process provides for efficient and compliant re-use & leveraging of Val information Reduces Compliance & Data Integrity risk with Data Entry Control/Verification & Automated process 11

12 Innovation ->> Challenges

13 Business Process Improvement Drive your IDEA to the Finish Line 5 Steps to Plan, Justify and Implement an e-val Solution Education: Learn the possibilities (traditional vs paperless e-val process) TRY IT OUT: Perform Test Run User-based Trial Define New Business Process & Develop Business Case Justification Confirm Management Approval for Implementation Plan & Funding Execute Plan: User Training & Deployment/Go Live

14 PRODUCTIVITY- EFFICIENCY- SPEED COMPANY GROWTH New Products/Sites 6 Reasons to Consider an E-Val Solution COMPLIANCE Data Integrity KNOWLEDGE TRANSFER VAL PROCESS ALIGNMENT & CONTROL INFORMATION ACCESS

15 Validation Types & e-val Business Process Activities Business Process Improvements: Typical e-val Business Process Activities 1 Initiate/Plan-(VRQ/VMP) Paper Based Process 40 steps E-Val Process 16 steps 2 Design Review 3 Prepare Requirements 4 Risk Assess (RA) 5 Prepare Trace Matrix Validation Types 6 Prepare Test Scripts 7 Prepare Val Docs Equipment Process Facilities Test Methods Computer Sys Packaging Sterilization Lab Instruments Cleaning Utilities Log Records Automation Sys Cold Chain Sanitization 8 Review Approve Val Docs 9 Execute Val Testing 10 Review Approve Testing 11 Process Deviations 12 Prepare Val Summary 13 Review/ Approve Val Summary 14 Publish Val Status 15 Release for Use/ Store Val Data 16 Maintain/Support (Changes, Reviews) 17 Val Status Monitoring 18 Access Val Information (Secure)

16 e-validation Business Process Solutions Typical e-val Process Activities 1 Initiate/Plan-(VRQ/VMP) 2 Design Review 3 Prepare Requirements 4 Risk Assess (RA) 5 Prepare Trace Matrix 6 Prepare Test Scripts 7 Prepare Val Docs 8 Review Approve Val Docs 9 Execute Val Testing 10 Review Approve Testing 11 Process Deviations 12 Prepare Val Summary 13 Review/ Approve Val Summary 14 Publish Val Status 15 Release for Use/ Store Val data 16 Maintain/Support (Changes, Reviews) 17 Val Status Monitoring e-val Solution: Enabling Services e-val Master Plan Management Requirements Management Risk Assessment Management Trace Matrix Management Library Services Val Docs Creation & Management Doc PACKS Generation e-routing -Review/Comments/Approvals e-test Execution Management (on-line) Val Deviations & Exceptions Management e-val Summary Report Generation Metrics & Status Dashboard e-val Data Repository Search and Reports Access Control 18 Access Val Information (Secure)

17 Validation Process Improvement Alternatives 01 Continue to Use Paper based process 02 Fine tune paper based process (elimninate unnecessary steps) 03 Use a hybrid system approach (paper & document management) 04 Customize an existing system 05 Select & implement a commercial COTS e-val system

18 Justification for e-validation System: The proposed solution provides a productive, cost effective, user-friendly and compliant e-validation solution to address all business process Pain Points and identified improvements Process Improvements Include: Streamlines and automates validation business process On-line test script management & execution with integrated exceptions management Enables cross-site Validation process alignment and extendibility Global real time Access to Validation Index, Val Status Information & Val Records Eliminates more than 50% of the manual paper process steps Productivity and Compliance Improvements Productivity improvements of 100%+ Work effort reduction of 50%+ Compliance assurance for Data Integrity and Record Accuracy

19 Typical e-val Solution Vision & Implementation Plan Val Types Planning Trial - Yes/No Month 1 Month 2 Month 3 Month 4 Equipment Lab Instruments Computer system Utilities Facility Cleaning Process Sterilization Test Methods Packaging Demo/ Clarify business needs Customer vision & business case defined Project proposal developed Trial objectives & success factors agreed NDA & Trial agreement established Trial Plan defined Trial team, Lead assigned Trial executed, e- val process results summarized Business case & proposal- mgmt Decision: Yes/No/delay Project Approval Standardized Val Business Process e-val System Requirements Approved e-val Project Implementation Plan Approved e-val Project Kicked Off Hardware / Software installed/ configurd Val Business Process configured Train User Master SMEs (one per site ) Validation of Customer Install Go Live PQ User Training Set upmaintain user accounts per COST N/A TBD BENEFITS Develop Plan Business Case Data ROI-PAYBACK N/A N/A LEVEL OF EFFORT RISK License & maintenance fee cost based on # users, validation execution reduced time and effort-refer to business case metrics chart refer to business case metrics chart minimal based on out of box GAMP 5 system -refer to resource chart definable-manageable--minimal based on customer experience

20 Typical e-val Solution Project: Timeline, Effort, Cost, Probability of Success, Benefits Typical e-val Solution Project Timeline 2-5 months from project kickoff (dependent on Business Process definition, effective project planning and management) Architecture alternatives of in house server hardware or SaaS hosted model deployment Typical Level of Effort to Implement Low level of internal resource efforts to set up/ configure /deploy based on effective project planning and management User role based training using e-train work instructions; internal application SME recommended for routine user support User access is typically web based-no separate user software installs Typical Cost to Implement TBD Typically Modest- Dependent on solution application licensing model and number of users License Model Alternatives: Named User (each user needs license) or Concurrent User (users have registered user accounts but share common licenses based on concurrent use (ie-20 concurrent licenses=100 + users with only 20 at same instance) Typical Risk/Probability of Success High probability of success with defined Business Process, effective project management, good user engagement and strong management support Typical Benefits Significant improvements in speed to completion, access to information and time/work efforts to complete validations High User Satisfaction, High Productivity, High Payback & ROI

21 Business Case Template Section 1: Background and Justification Background Problem Statement Proposed Solution Alternatives Justification Section 2: Current State Challenges vs Improvements with proposed e-validation Solution Section 3: Solution Functionality to Achieve Improvements Section 4: Benefits Section 5: ROI Note: The Information in previous slides can be used to develop your Business Case

22 Business Case Justification e Validation Solution - Example: Payback Summary Validation Process Activity Summary e-val Solution vs Current Process (Example) Activity/ Effort (Hr to complete) Current Process e-val Solution Net Difference Comments 1.Plan (VRQ/VMP 3 Hr 1 hr 2 hr 2.Design Review 4 hr 3 hr 1 hr 3.Requirements Management 5 hr 2 hr 3 hr 4.Risk Assessment 5 hr 2 hr 3 hr 5.Test Script Prep 5 hr 2 hr 3 hr 6.Trace Matrix Create 4 hr 1 hr 3 hr 7.Val Docs Create 8 hr 5 hr 3 hr 8. Review & Approve Val Docs 8 hr 2 hr 6 hr (Requirements, Trace, Risk, Val Docs) 9.Execute Val Testing 12 hr 6 hr 6 hr 10.Review/approve Testing 8 hr 3 hr 5 hr 11.Deviation Processing 8 hr 3 hr 5 hr 12.Val Summary create 6 hr 1 hr 5 hr 13.Review/Approve Val Summary 6 hr 1 hr 5 hr 14. Publish Val Status/Metrics 3 hr 0 hr 3 hr 15. Val Records storage 3 hr 0 hr 3 hr Totals Payback Summary 1.#Val Protocols per yr: Savings per protocol (all val activities( 3.Total Savings per yr- Savings per protocol X # protocol 4.Other savings (ie--copy & scanning reduction) Savings per Val Protocol (All Val Activities) 56 hrs per protocol 56 hr Total estimated annual savings hr/yr Comments

23 Thank You Questions? Contact Information: Lou Killian Director Customer Success, Kneat Solutions 23

24 Implementation of a ELMS e-validation Case Study - BioPharma

25 Company Background Global BioPharma Company Commercial and Clinical Products Drug Substance, Drug Product, Fill Finish Operations, and Medical Device Validation Department Facility, Utility, and Equipment Validation 700+ protocols Globally/Year 20+ Year history Validation Work Process SOP Based Documents Standard QA Approved Forms Pre-Approval and Post Approval Slide 25

26 Business Needs / Drivers Initial Project Scope Equipment Validation Group IQ, OQ, and PQ Facilities, Utilities, and Process Equipment Cleaning and Sterilization Validation Validation Repository Storage of Scanned Protocols Validation Meta-data to Support Manufacturing Document Retrieval for Audits Slide 26

27 Business Needs / Drivers Project Mission Statement To Develop a Sustainable, Lean Validation System Utilizing State of the Art Technology to Integrate Data, Streamline Validation Work Flow and Manage Risk Slide 27

28 Mission Statement - Sustainable Reduce Environmental Impact Paper, Toner, Plastic Storage Waste Compliance Human Error Global Harmonization Data Integrity Business Time to Market Cost of Compliance Slide 28

29 Mission Statement - Lean Simplify and Streamline Work Process Reduce Number of Process Steps Focus Resources on Critical Tasks Reduce Administrative Tasks Synchronize Activities Right Time Right Scope Maintain / Improve Quality Reduce Human Error Improve Information Flow Slide 29

30 Mission Statement Integrated Data Single Source Shared Data Across Disciplines and Documents Integrate Work Process Engineering, Commissioning, and Validation Right Time Testing / One Time Testing (Leveraged) Construction Quality Engineering Change Control Slide 30

31 Mission Statement Risk Management ASTM E2500 Impact Assessments (SIA) Component Criticality Assessments (CCA) Focus the Validation Effort on Critical Components and Functionality Slide 31

32 Validation Work Process - Change Key Changes Parallel Review Electronic Routing No Physical Inventory Less Handoffs Slide 32

33 Original Validation Work Process High 10 Medium 5 Round Time Non Stop: Steps 1848 Miles 0.88 Time 16:11 Calories 69.6 Low 0 Current Work Flow Electronic Work Flow Target Slide 33

34 Original Validation Work Process Areas of Improvement Protocol Generation (Static Data) Protocol Routing (Serial No Collaboration) Inventory (In Progress Protocols) Logistics (Corrections to Document) Tracking (No Real-time Data / Metrics) Slide 34

35 Original Validation Work Flow Protocol Generation (Static Data) Protocol Generation cannot be Automated or Copied Recording Redundant Information Hand Written Form Completion is Inconsistent Not Always Legible Test Information Located in Multiple Documents Manual Data Mining Slide 35

36 Original Validation Work Flow Protocol Routing (Serial No Collaboration) Communication Tools (Face to Face or ) Reviewers Do Not See Each Others Comments Possible Multiple Review Rounds Difficult to Expedite (Who s Available?) Slide 36

37 Original Validation Work Flow Inventory (In Progress Protocols) Office Supplies Binders, Paper, Sheet protectors, and Tabs Printers and Toner Physical Storage Office Supplies In-Progress Protocols Generation Execution Protocol Archival Protocol Tracking and Management Potential for Lost or Misplaced Protocols or Forms Slide 37

38 Original Validation Work Flow Logistics (Correction To Document) Transit Time Multiple Hand offs Routing Corrections Deviations For Execution Distance between Personnel Tracking Document Location Status Expediting Work Flow Availability of Personnel Slide 38

39 Original Validation Work Flow Tracking (No Real-time Data / Metrics) Protocol Status (In-Progress) Multiple Tracking Systems Manual Updates Communication Issues (Not Always Notified) Protocol Status (Legacy) Multiple Tracking Systems Manual Updates Manual Data Mining from Multiple Sources Slide 39

40 Solution Selection Status Quo Document Management System (DMS) Protocols Scanned and Routed Print and Execute Route and Scan Approved Document DMS and MS Word ECDB Word Generated Protocols Print and Execute Route and Scan Approved Document Status Quo with Validation Repository Full E-Life Cycle Management System (ELMS) Slide 40

41 Solution Selection Slide 41

42 E-Validation Solution Estimated Savings Reduction Of Steps (39 To 16) Hour Estimates For Reduction Of Steps And Work Savings Will Roll-in With Roll-out Document Transportation Office Supplies Data Mining Protocol Generation and Execution Scanning Archival Estimated Savings $1.1M/year Slide 42

43 Implementation Solution Testing Proof Of Concept Software Validation Training E-Learning Vendor Training Workshops Went Live September 2015 Validation Department December 2015 Manufacturing Change Over October 2016 Commissioning Added January 2017 Analytical Instrument Validation Slide 43

44 Results Validation Test Protocol Cycle Time Reduced by 60% Test Protocol pre-execution approval time was reduced by 48% on average across all sites Test Protocol post-execution approval time was reduced by 58% on average across all sites 50% Savings in labor hours The E-Validation Solution allows staff to apply their skills by eliminating frustrating clerical type paper based activities. It removes the chain that is the paper system. Change Over 85% reduction in labor time Slide 44

45 Additional Benefits Global Standards Harmonization of Sites Controlled Evolution No more Frankenstein Documents Resource Utilization Global Resources (Plug and Play) Subject Matter Experts Online Test Execution (Multi-Person / Same Protocol) Project Management Real-Time Information Global Resource Pool Standardization of Work Process Sharing Best Practices Slide 45

46 E-LMS Expansion Integrated Engineering, Commissioning and Validation Automation Validation Process Validation and Tech Transfer Regulatory Fillings E-Batch Records Medical Device?????? Slide 46

47 Challenges and Lessons Learned Implementing New Technology Culture Change Training (Timing and Content) Personnel Engagement Not Just Paper to Glass Change How We Think Optimizing for Electronic Converting Management Tools to New Business Process Individual Targeted Training 3 Groups of People (Learning Curve) Management Support Slide 47

48 Where Do We Go From Here? Technology S Curve MS Word Peaking ELMS More Room to Grow Maximizing Benefit Reduced Time to Market Risk Mitigation One Site ELMS Compliance (Risk) Slide 48

49 Pushing the Limits of a System A 3.0 Second Pit Stop is Great Until A Wheel Comes off To Get Faster Results We Need to Change The System Slide 49

50 Questions? Slide 50