1. ValGenesis Enterprise Validation Lifecycle Management System ValGenesis, Inc. 47102 Mission Falls Court, Fremont, CA 94539 Ph: 510.445.0505 : www.valgenesis.com

2. ValGenesis, Inc. Vision Best-in-Class system for Validation Lifecycle Management Process Team Years of combined industry experience in pharmaceutical drug substance and drug product manufacturing, quality, and information technology Industries Pharmaceuticals, Biotech, Medical Device Clients Global Regulated Life science companies - Bayer, Amgen, Roche, ……… Technology 100% Web-based system scalable from a single site deployment to a multi-location global deployment Awards PDA New Innovative Technology Award for providing an innovative software platform

3. Enterprise Islands of data Execute Review Approve Create Audits Peer Review Instrument Validation Instrument Validation Process Validation Cleaning Validation CSV Method Validation Equipment Validation Equipment Validation DMS LIMS Current State of Corporate Validation Process No Single View of the Quality Status and Validation Information Validation Manager Process Data Process Data Validation Data Process Data LIMS Process Data DMS Validation Protocol ? ? ? ? ? ? ? ? ? ? Difficult to Track Inefficient Collaboration Time consuming Audits

4. Validation Lifecycle and Change Management

5. Enterprise Global View Execute Review Approve Create Audit Peer Review Process Validation Cleaning Validation CSV Method Validation Equipment Validation Equipment Validation Instrument Validation Instrument Validation Holistic View Efficient Collaboration Successful Audits Central Validation Management DMS LIMSERP MES LMS QMS After Implementing ValGenesis – Efficient Validation Process

6. Benefits of Electronic Validation Management System Cohesive Directional Information  Once implemented, all validation processes become more manageable  Adaptable paperless validation with existing IT structure and business rules  Dashboards and reports to locate bottlenecks in the validation process  Provides genealogy of corporate validation in real time Cohesive Directional Information  Once implemented, all validation processes become more manageable  Adaptable paperless validation with existing IT structure and business rules  Dashboards and reports to locate bottlenecks in the validation process  Provides genealogy of corporate validation in real time Compliance  Designed to adapt to and comply with regulatory requirements  Facilitate industry validation standards including GAMP 5.0 and ASTM E2500  Facilitate timely collection of data in preparing for internal and external audits Compliance  Designed to adapt to and comply with regulatory requirements  Facilitate industry validation standards including GAMP 5.0 and ASTM E2500  Facilitate timely collection of data in preparing for internal and external audits Consistency  Facilitates consistency through templates and reusing documents  Manages validation procedures through best practices  Simplifies through electronic access to validation data and documents Consistency  Facilitates consistency through templates and reusing documents  Manages validation procedures through best practices  Simplifies through electronic access to validation data and documents Cycle Time  Studies indicate that ValGenesis reduces validation cycle time by 30 - 50%  Configurable to meet existing business rules for faster Ready for Service and quicker Return on Investment Cycle Time  Studies indicate that ValGenesis reduces validation cycle time by 30 - 50%  Configurable to meet existing business rules for faster Ready for Service and quicker Return on Investment

7. ValGenesis System Overview  100% browser based system with zero footprint clients  Compliant with 21 CFR Part 11 and Annex11  Integrates with your LDAP or Active Directory  User and Role level security  Support  Offline Data Entry Capability  eMail Notifications  Alerts & Escalations  Out of office delegation and Task Reassignment  Serial / Parallel / Combination Workflows  Web Service and API integration  PDF generation with watermarking  Ad-hoc Report Writer

8. Continuous Monitoring ValGenesis Validation System Platform Forms DesignerWorkflow DesignerProcess Flow Designer Flexible Designer Validation Framework Risk Management (FMEA and ASTM) Dynamic Trace Matrix Change Management Protocol Execution Management Validation Status Monitor/Control Protocol/Content Authoring Validation Project Periodic Review Management Requirements Management PM Tools KPI DashboardAd hoc Query/ReportingBusiness Analytics KPIs/ Metrics

9. Tracking and Reporting Features “We have…” Benefits “It Will…” Value “Which Means…” Document Pie ChartsImproved management of document deliverables Find out the bottle necks process Delivery on time Inventory ManagerSingular repository for document deliverables, change controls, and system validation status Track validation of status in real time Holistic view of validation status Always prepared for Audits Ad Hoc ReportingAny type of report can be generated Reports can be exported to MS Office tools Report on any data & document Metrics reports Granular and easily share reports Validation CalendarProvides visibility to all the cross functional groups about the upcoming Periodic review of any system site/corporate wide Minimizes the impact of periodic review schedules on other regular activities

10. Status of Documents under Development Documents Under Development Pie Chart displays all of the documents being developed. Each section of the pie chart represents a different phase in the development life cycle Click on any pie chart section to view the documents that are in the selected phase

11. Example of Process Flow Accessible through Pie Charts When Val. Doc. No. or Val. Exe. No. is clicked for list of documents being developed, executed, reviewed, or approved from Development and Execution Pie Charts, the Process Flow is displayed. Process Flow indicates where the document is and where it is going next

12. Categories Sub Categories Entities Inventory Report provides a holistic view of the corporate validation status. Real time validation status or Audit trail of any entity or documents can be found in few mouse clicks through this inventory report. Inventory Report in Dashboard

13. Example of Metrics Report for a User Metrics reports for users will display all of the tasks that have been completed by the user Filtering options available to display tasks completed over a given time frame

14. Delayed Schedule Tasks displayed in Red Font Delayed Schedule Tasks displayed in Red Font Current Schedule Tasks displayed in Green Font Current Schedule Tasks displayed in Green Font Future Schedule Tasks displayed in Blue Font Future Schedule Tasks displayed in Blue Font Upcoming Periodic Review and Revalidation schedules will be captured and displayed in the Validation available in dashboard. Validation Calendar –Revalidation Schedules

15. Frameworks and Projects Features “We have…” Benefits “It Will…” Value “Which Means…” Validation FrameworksStandardized document deliverable requirements that determine validation status of any system Consistency in validation Ensures that all key deliverables are Project DesignerAssign Project Managers to manage validation throughout project lifecycle Set deliverables in phases to enforce quality gate checks Real time document status updates Simplifies project management with real time document tracking Enforces document to document and system to system dependencies Controlled Approval Workflows Frameworks, projects, and project summaries routed through controlled user defined workflows to enforce consistent validation procedures Consistent workflows Enforce validation policies and procedures derived from SOPs and policy documents

16. Enforce Document Deliverable Requirements Enforce validation policies and procedures derived from SOPs and policy documents Level of Documentation required is based on the risk level Level of Documentation required is based on the risk level

17. Document Authoring Features “We have…” Benefits “It Will…” Value “Which Means…” Develop documents using MS Office tools Author, Review and Approve documents quickly using tools already familiar with end users Leverages existing infrastructure No need to learn new tool to manage validation documents Template driven development Develop from pre-approved templates stored within a single repository Enforces document consistency Simplifies template management through single repository Test function management Define standard tests that can be reused across several documents Accelerates document authoring through test functions Enforces document consistency Controlled workflowsUser defined workflows to manage review and approval of documents Documents can be routed in parallel to accelerate review and approval Documents routed electronically Accelerates review and approval Eliminates possibility of lost documents Simplifies management of documents through controlled workflows

18. Features “We have…” Benefits “It Will…” Value “Which Means…” Dynamic Trace Matrix generation Trace matrices can be built in the system in three easy steps System automatically links requirements to tests Ensures that requirements have been tested thoroughly Provides forward and backward traceability Impacted requirements automatically updated Dynamic update to trace matrix to illuminate any requirements that may be impacted as a result of testing failures Easy to conduct regression testing Real time information related to testing and requirements Controlled workflowsUser defined workflows to manage review and approval of trace matrices Accelerates review and approval Manages trace matrices like any other validation deliverable Requirements management Requirement changes illustrated directly on trace matrix System provides ability to add, modify, or delete requirements Simplifies management of requirement changes Automatically updates impacted traceability matrices Dynamic Traceability Matrix

19. Passed Tests Highlighted in Green Passed Tests Highlighted in Green CQP and Verification Test cases Linked Easily through Checkboxes CQP and Verification Test cases Linked Easily through Checkboxes Failed Test Cases Highlighted in Red Failed Test Cases Highlighted in Red Unexecuted Rows Highlighted in Orange Unexecuted Rows Highlighted in Orange Good Engineering Practice (GEP) should underpin and support the specification, design, and verification activities. CQPs are living data and linked with other data sources. Dynamic Traceability

20. Features “We have…” Benefits “It Will…” Value “Which Means…” Electronic ExecutionExecute documents electronically without paper Quantify test results for each test with screenshots and supporting files Eliminates possibility of lost documents Captures user name and date and time stamp for each row executed No more lost screenshots and file attachments Deviation ManagementManage deviations electronically Accelerate deviation assessment and management through controlled workflows Deviations assessed, resolved, reviewed, and approved quickly Simplifies management and tracking of deviations Execution MetricsTracks execution metrics during an execution Provides a clear picture of execution including the number of tests, test results, and deviations Controlled workflowsUser defined workflows to manage review and approval of documents Documents routed electronically in serial or parallel Accelerates review and approval Eliminates possibility of lost documents Electronic Execution and Deviation Management

21. Electronic Execution Screen Shots are Captured and Populated Dynamically at the Row Level Screen Shots are Captured and Populated Dynamically at the Row Level User ID with Date and Time Stamp Captured for Each Row Executed User ID with Date and Time Stamp Captured for Each Row Executed Test Results are Populated Dynamically Test Results are Populated Dynamically Supporting files can be attached at the row level Supporting files can be attached at the row level

22. Validation Schedule Management Features “We have…” Benefits “It Will…” Value “Which Means…” Periodic review management Define any number of periodic review schedules Easily manage periodic review schedules and associated tasks Simplify management of complex periodic review schedules Automatic alert notification for upcoming schedule tasks Users can better plan their tasks and avoid missing the critical GMP system from being not reviewed as per SOP Ensures that critical GxP entities are revalidated and periodic reviews completed in a timely manner Automatic alert notification for delayed schedule tasks Take necessary actions including expedite the periodic review/revalidation with grace period or initiate CAPA etc. Mitigates risk of non-compliance Ensures that systems stay within defined compliance parameters

23. Include Changes after an Assessment Include Changes after an Assessment Upcoming Periodic Reviews and Revalidation Tasks can be included in an Assessment Upcoming Periodic Reviews and Revalidation Tasks can be included in an Assessment Maintain Validation Status through Assessment

24. Initiate Incident/CCR/DCR Initiate Incident/CCR/DCR Review Compliance Team Assessment Compliance Team Assessment IT Assessment IT Assessment Vendor Assessment Vendor Assessment Compile and Review Compile and Review IT Updates Incident/CCR/DCR Closed Incident/CCR/DCR Closed Initial Release Notes Initial Release Notes Closed Loop Change Incident/CCR/DCR Management Process Develop Release Summary Develop Release Summary Approval Review/Approve Final Release Summary Review/Approve Final Release Summary QA Assessment QA Assessment Update System Update System Validation QA/Compliance Approves QA/Compliance Approves Post Approval

25. Integrated Solution for Validation Lifecycle Management Process Validation Plan and Projects Yes Requirements Management Yes Document Development Yes Template Approach Yes Supports MS Word and Excel Yes Electronic Execution Yes Deviation Management Yes Automated Execution Yes Dash Board – Real time Status Yes Validation Metrics Yes Change Management Process Yes Periodic Review Yes Dynamic Traceability Matrix Yes Risk Assessment (FMEA and ASTM) Yes Revalidation Scheduler Yes Content Management Yes ValGenesis Documentum and LiveLink (DMS) TrackWise, ETQ etc. (QMS) Blue Mountain (Calib. Systems) HP QC and QTP (Auto. Testing Tools IBM Rational Rose (Req. Mgmnt. Tools) SAP and Oracle ERP (ERP Systems)

26. Connector for EMC Documentum ValGenesis can be leveraged as user interface to Documentum to manage the validation lifecycle process Taxonomy created in ValGenesis will be dynamically created in a specified Documentum Cabinet Approved ValGenesis documents (Templates, Requirements, Developed Protocols, and Executed Protocols etc.) will be available in a specified Documentum Cabinet Documents authored in Documentum can be synchronized with ValGenesis to create traceability matrix and to execute electronically, the final approved documents will be stored in Documentum Reference documents such as SOPs, User Manuals etc. available in Documentum can be bound within ValGenesis, these reference documents will be available as hyperlinks in ValGenesis during the validation process Validation documents and data generated in ValGenesis are available to Documentum users

27. Enterprise Service Repository o Validation Status of New Equipment o Upcoming Period Review o Risk Assessment Details o Master Recipes o Material Details o Resources & Functional Locations GxP Asset Info o Validation Status of New Equipment o Upcoming Period Review o Risk Assessment Details o Master Recipes o Material Details o Resources & Functional Locations GxP Asset Info SAP xMII Architecture – Overview SAP ERP SAP NetWeaver Industry Standard Business Packages (e.g. S95) MMQM PP/PI BAPI/RFC/IDOC Repository XI BW EP PM SAP xMII Core Manufacturing Services APOCRM… ValGenesis Test Case Management Test Case Execution Risk Management Periodic Review Change Management Validation Plan & Projects SAP - ValGenesis Integration Validation Status Validation Status Update Plant Maintenance Plan Material Consumptions Quality Notifications Validation Data & Documents Maintenance Notifications Validation Status Validation Status Update Plant Maintenance Plan Material Consumptions Quality Notifications Validation Data & Documents Maintenance Notifications Requirements Management Traceability Matrix

28. BEFORE VALGENESIS RESULTS WITH VALGENESIS Impact of ValGenesis Implementation Inconsistent Documentation Template driven development Improves consistencies Approvals are tracked and alerts through corporate e-mail are sent out Review and Approval Delays Dynamic audit trails provide real time validation status and metrics Ineffective Tracking Automated alert notification to SMEs regarding periodic reviews Missed periodic reviews A click of the mouse and everything is ready Time consuming audit preparation Difficulty enforcing validation standards and policies Helps to enforce validation standards, policies and procedures Scanning documents and electronic management Web-based system allows for approvals on-line with full view of documentation

29. Elimination of Non-Value Added Activities  Creating Binders  With Electronic Validation, Binders are no longer required  Document Storage  Documents are stored electronically in the system.  ValGenesis generates approved documents into PDF with watermark  Locating Document in Archives  Since documents are stored electronically, there is no need to find documents in a document archive  Tracking mechanisms available to locate bottlenecks quickly  Bottlenecks in process can be located easily

30. T Ph: 510 445 0505 Email: info@valgenesis.cominfo@valgenesis.com www.valgenesis.com hankYou Thank You