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Enterprise Compliance Management Solution

Enterprise Compliance Management Solution. Tim Fischer EtQ Enterprise Account Executive Tom Barlow EtQ Pre-Sales Engineer. ISO Certifications. The GoToMeeting Attendee View. Agenda. Reliance TM. Overview Overview of EtQ, Inc. EtQ Reliance Product Overview

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Enterprise Compliance Management Solution

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  1. Enterprise Compliance Management Solution Tim Fischer EtQ Enterprise Account Executive Tom Barlow EtQ Pre-Sales Engineer ISO Certifications

  2. The GoToMeeting Attendee View

  3. Agenda • Reliance TM • Overview • Overview of EtQ, Inc. • EtQ Reliance Product Overview • Interactive Reliance Demonstration • EtQ Portal & Reporting • 3 top Priority Modules to be reviewed • EtQ Designer (configuration tool) • Wrap-up

  4. Core Messaging Statement EtQ is the leading Enterprise Quality and Environmental Health and Safety Management Software for identifying, mitigating and preventing high-risk events through integration, automation and collaboration. EtQ uses best-in-class integrated solutions and enterprise application integration to manage and measure Quality and Environmental Health and Safety processes and execute organizational change.

  5. Who We Are • The Company • Founded in 1992 as a Quality Consulting Organization • Founders’ background is in Quality and Environmental • First software product: 1995 • Financial Health • Independent company • No external capital • No debt • Consistent 35% sales growth per year over past 5 years • Profitable since inception • R&D re-investment is 22% alone • Strong maintenance revenue stream • Over 95% retention rate over past 5 years

  6. Market Intelligence - Gartner • Gartner’s take on EtQ • “The information (EtQ) shared led us to rate their financial condition as positive…it has no debt, no external capital, reinvests an amount typical for the QMS software market in product R&D and with an excellent maintenance revenue stream from a large customer base including many Fortune 100 companies we believe it represents little risk.” • “EtQ's strategy in the QMS space aligns well with Gartner's view of how the market is evolving”.

  7. Market Penetration EtQ customers come from many market segments…

  8. Customer-Centric Company • Install base • Over 500 companies • Over 1,000,000 users to date • Across 4000+ sites

  9. Module Breakdown For more details: ETQ Online Modules Matrix www.etq.com/modules/matrix.shtml

  10. Module Breakdown

  11. What We Offer http://www.etq.com/modules/matrix.shtml • Environmental Health and Safety • Comprehensive integrated suite of modules built on the EtQ Reliance Platform to meet the needs of EH&S Management standards and initiatives: • Features comprehensive set of utilities

  12. What We Offer http://www.etq.com/modules/matrix.shtml • Quality Management Solution • Comprehensive integrated suite of modules built on the EtQ Reliance Platform to meet the needs of Quality Management standards and initiatives: • Features comprehensive set of utilities

  13. What We Offer http://www.etq.com/modules/matrix.shtml • Good Manufacturing Practices • Comprehensive integrated suite of modules built on the EtQ Reliance Platform to meet the needs of GMP standards and initiatives: • Features comprehensive set of utilities

  14. What We Offer http://www.etq.com/modules/matrix.shtml • Food Safety Management Solution • Comprehensive integrated suite of modules built on the EtQ Reliance Platform to meet the needs of Food Safety standards and initiatives: • Features comprehensive set of utilities

  15. What We Offer http://www.etq.com/modules/matrix.shtml • Aviation Safety Management Solution • Comprehensive integrated suite of modules built on the EtQ Reliance Platform to meet the needs of Aviation Safety Management standards and initiatives: • Features comprehensive set of utilities

  16. Customer Benefits through EtQ

  17. EtQ RelianceTM

  18. Market Intelligence - Gartner • Gartner’s take on Reliance • “In the QMS space we consider Reliance to be a benchmark product, that is one that most companies will see as having among the richest and most comprehensive feature sets and against which they tend to compare other solutions. The functionality offered in Reliance should meet or exceed most manufacturers QMS needs.“

  19. EtQ Reliance - Platform Approach • Configurable workflow-based business process automation tool • Web-based • Flexible and Easy to Use • Industry Standard Technology • Workflow automation • “Out-of-the-Box” Best Practices • Configurable without programming • Designed for Integration and Scalability • Platform Wide Utilities • Designer | Integration | Centralized Reporting | Quantitative Risk Assessment

  20. Scalability • Enterprise Configuration Center • Manage any size of organization – single site or global • Ensure users see only what is appropriate to their role / site • Control user, group and location security from a single application • Manage data from a single application • Interact with other systems • ie. SharePoint, SAP, external databases • Reduce IT overhead • Speeds implementation time

  21. Internationalization • Language Preference • Each user can specify their preferred language based upon browser settings • Local Date and Number Format • Dates, times and numbers are automatically displayed and captured in the user's local format • Double-byte Character Support • EtQ Reliance also supports Double-Byte Character Set (DBCS) such as Japanese, Chinese and Korean • Multi-Language Global Roll-up Reporting • Keyword fields store their values as unique ID code to allow global roll-up reporting across multiple languages, regardless of the language used to select the values

  22. Deployment Options • On Premises Deployment • Reliance is installed in your facility • Administration performed by your IT group • You purchase Reliance & support it internally • Hosted • EtQ Reliance is installed in a hosted environment • Administration is performed by EtQ Technical Services • You purchase Reliance and hosting fees for EtQ to support it • Software as a Service (SaaS) • EtQ Reliance is available on a subscription basis • Administration is performed by EtQ Technical Services • You purchase a subscription to access the software • You own your data only

  23. Integrated Solution

  24. EtQ Reliance Designer EtQ Designer: Workflow EtQ Designer: Forms EtQ Designer: Views

  25. Timeliness, Efficiency and Accountability Email Immediate Assignment and Notification Escalations Automated reminders involving others if necessary Delegation Assign review and approval duties to a delegate Electronic Signatures Comment History or Force Authentication 21CFR Part 11

  26. 21 CFR Part 11 Compliance Features • Additional Security features added to EtQ Reliance • Designed to exceed compliance with the FDA 21 CFR Part 11 rule • Electronic Signatures and Records, Audit Trail and Security • High-Level Features: • Electronic Signature Binding: Automatically and securely binds the authenticated user's electronic signature, and forces authentication every time a record is processed • Audit Trail: Display the Audit Trail for a specific field, a specific event (phase) or for the entire record • Enhanced Password Security: Automatic password aging with configurable expiration and warning periods, as well as automatic protection against repeated attempts to log in without proper username and password • Regulatory Compliance Workflow: Best Practices and workflows designed to support regulatory requirements

  27. Integration • Create synchronized MS Office attachments • Synchronize Word and Excel attachments • Synchronize MS Project files with Reliance Projects • Publish to MS SharePoint • Synchronize Users and Groups from Directory Services • SAP Certified Integration • Provide links to External URLs • Real time JDBC lookups from external systems • Configurable Connection Profile • Delimited Text, JDBC/JNDI or XML • Full Featured API Table (Data Repository) EtQ APIs: (Java, XML, Web Services) EtQ APIs: (Java, XML, Web Services)

  28. Centralized Reporting: • Multiple formats • Scheduled, ad-hoc, portal • Search, filter tools • Export to Excel, PDF • Use 3rd party tools

  29. Multi-Level Drill-Down Reporting Centralized Reporting: Centralized Reporting: • LEVEL 1 • What did it cost for each product line? • LEVEL 2 • What is the breakdown on ABC? ... just “click”

  30. EtQ RelianceTM Summary • A fully automated, configurable workflow-based business process automation tool • Web-based • Workflow automation • Industry Standard Technology • “Out-of-the-Box” best practices • Configurable without programming to meet your unique needs • Integrates with 3rd party applications • Allows use of multiple languages • Enterprise reporting tools • Risk Assessment tools • Timeliness and Accountability tools

  31. Demonstration

  32. EtQ Professional Services Model

  33. Project Management Paradigm Traditional Resource Level Avoid Post Release Problems Actual or Unplanned Resource Level Resource Level Time Expected Resource Level with EtQ Implementation Process

  34. EtQ Design Model Understand the Business Need Business Case SIPOC Analysis Detailed Process Mapping and Output Success Criteria Translate Business Need into Software Design Detailed Design Specifications Approval of Specifications prior to Configuration

  35. Project Roles and Responsibilities EtQ Roles: EtQ Executive Sponsor:Member of the EtQ Executive team. Provides executive-level support to the project, if needed. EtQ Professional Services Manager:Manages all EtQ IC, Technical IC and PSA resources. Responsible for assigning and scheduling those resources. EtQ IC (Implementation Consultant):System analyst assigned to the project. Responsible for translating business requirements into system configurations. Coordinates project activities with other EtQ resources. EtQ Technical IC:System configurator assigned to the project. Responsible for training the customer and implementing the configurations. EtQ Validation IC: Implementation Consultant involved in training and execution of validation services. EtQ PSA (Professional Services Assistant):Project coordinator assigned to the project. Responsible for tracking scheduled activities and project milestones. EtQ Installer:Responsible for installing the hosted and onsite copies of the system. EtQ Development:Responsible for developing custom functionality for the system. EtQ TS (Technical Support): Responsible for providing online technical support for the system.

  36. Project Roles and Responsibilities Customer Roles: Project Sponsor:Customer representative ultimately responsible for the success of the system. Approves significant changes to the project scope. Project Manager:Customer representative responsible for managing the project on the customer's side. Reliance Administrator:Customer representative responsible for leading the implementation of the new system. Performs most of the administration and configurations, in collaboration with the Process Owners. Process Owner:Customer representative responsible for the implementation of a specific module. Provides business requirements and may perform administration and configurations as well. System Administrator:Customer representative responsible for providing IT support to the project. Requires access to the infrastructure hardware and software on which the system is running. Validation Team:Customer representatives responsible for system validation. Technical Team:Customer representatives responsible for supporting advanced configurations, migration or integration. End Users:Responsible for testing the configured system for use in production.

  37. SIPOC Overview

  38. SIPOC Overview

  39. Process Mapping

  40. Word Form Mock-up

  41. Visio Workflow Mock-ups

  42. Detailed Design Specifications

  43. Project Plan Overview

  44. For more info on www.etq.comblog.etq.cominfo@etq.com800-354-4476 ISO 9001 System Certifications

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