Case Study: Implementing an e-validation Solution within a BioPharma Company

Transcription

1 Case Study: Implementing an e-validation Solution within a BioPharma Company

2 Index Company Background Business Drivers Alternatives Identified Solution Justification Implementation Strategy Solution Implementation Process Results Outcomes Additional Accomplishments Recommendations/Lessons Learned

3 Customer Company Background BioPharma: multi site & multi-country Commercial & clinical phase products Company Growing: facility expansion, new site construction and acquisitions, new products Existing Quality IT Systems including ERP, Content Management and QMS (Deviation/CAPA) Corporate Quality Validation Policy and Guidance Documents established Validation paper based with final validation packages archived as scanned PDF copies Good regulatory inspection history with some observations relating to site validation inconsistencies

4 Business Drivers Company Growth Compliance Challenges Knowledge transfer Products and site expansions increasing demand for timely validation services Test execution errors, Deviation management, Lost records, Data Integrity concerns. Val Status Information not readily available. Historic Val information not effectively captured for Sharing and Reuse Productivity Current Val processes manual, inefficient and labor intensive; Val resources quantity/cost rapidly increasing Speed/Predictability Time predictability for completion of validation activities very challenging; Critical Path project deadlines occasionally not met (reg submission impact) Information Access Real time Val and project status information not available. Historic Validation content not readily available when and where needed

5 Alternatives Considered 1. Continue to use current paper based validation processes 2. Lean out existing validation process - eliminate unnecessary steps 3. Add resources to support increasing validation demands 4. Customize existing content management system to address validation process needs 5. Develop internal custom system to address validation process needs 6. Assess/Select commercial e-validation solution to address business process needs

6 Identified Solution Management authorized Alternative 6 ( Select commercial e-validation Solution) High level Future State Business Process and User Requirements Defined 3 commercially available e-validation Solutions identified and assessed against User Requirements 2 e-val solutions selected for trial 1 solution selected to implement (functionality, ease of use, adaptability to future business process needs)

7 Justification for Project Proposal Project champion summarized benefits of e-val Future State business process vs Current State process Project champion got buy-in from Project Sponsor and key stakeholders Key Val Process improvements Data from e-val Solution Pilot compiled in Business Case format Business Case Summary showed significant Payback/ROI from e-val solution Key Benefits: Cross Company Val process alignment Productivity and Compliance improvements Real Time Val Status information Quick & easy e-access to Val information Ease of extendibility to new sites

8 Implementation Strategy Scope of e-val solution project: All Validation Types (Process, Equipment, Cleaning, Facilities, Utilities, Sterilization, CSV, etc) Global /Enterprise e-val Solution implementation - All Sites Legacy Val information loaded to new e-val Solution Incremental implementation based on business priorities: Val Types prioritized for implementation Site implementation scheduled (could be concurrent or staggered) Legacy Val data scheduled for import after Val types implemented Other: Establish Steering Committee assign corporate implementation performance goals Establish full time Project Manager and team with assigned business SMEs for each site Leverage experience and support of e-val Solution Vendor Leverage out of box configurable functionality

9 Implementation Project Charter and Project Implementation Plan Establish Project schedule, Resource plan and Issues Resolution plan Establish Steering Committee and Project Team (multi-site & vendor) Establish Application Software environments including training/ practice environment Vendor Audit Application Validation - leverage vendor Validation package using Risk Based Validation approach Prepare SOPs, Train Users, Perform UAT Go Live

10 Results Project items implemented per schedule (thanks to effective project mgmt/vendor support) Very Positive User and Management feedback from all sites; Effective Post Go Live support team identified and resolved issues quickly Val process alignment achieved; (sites collaboration team working on additional Val process improvements) Productivity improvements (payback) exceeded expectations (refer to chart)

11 Results

12 Additional Accomplishments Company wide Validation Registration Index being developed to track History and Status of all Validations System being configured for managing and archiving Equipment and Facility Vendor Turn Over Package Records

13 Lessons Learned Effective Sr Management Project Sponsor, Steering Committee, Project Manager Enthusiastic and knowledgeable Business Process Owner/Champion Well trained Business SMEs (at all-sites) for new e-val Solution Effective Communication program: What s Coming, Impact to You, Questions Hot Line Active multi-site Collaboration Team Members who provide both Pre and Post Go Live Support Celebrating and Communicating Achievements - milestones, team recognition Value of establishing parallel project team for Legacy Val Data import

14 Thank You Questions? 14