confidential: this document contains information that is confidential and proprietary to etq, inc....

CONFIDENTIAL: This document contains information that is confidential and proprietary to EtQ, Inc. Disclosure, copying, distribution or use without the express permission of EtQ is prohibited. Copyright 2013 EtQ, Inc. All rights reserved.

Enterprise Compliance Management Solution

Tim FischerEtQ Enterprise Account Executive

Tom BarlowEtQ Pre-Sales Engineer

ISO Certifications

The GoToMeeting Attendee View

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

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.

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

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”.

Market Penetration EtQ customers come from many market segments…

Customer-Centric Company• Install base

– Over 500 companies– Over 1,000,000 users to date– Across 4000+ sites

Module Breakdown

For more details:

ETQOnline Modules Matrix

www.etq.com/modules/matrix.shtml

Module BreakdownModules - As of version 10.0 of EtQ Reliance: QMS GMP EHS F&B SMSAudits Management • • • • • Calibration and Maintenance • • • • • Change Management • • • • • Complaints Handling • Corrective Action and Preventive Action (CAPA) • • • • • Emergency Preparedness Plans • • Customer Feedback • • •Deviation • • • • • Document Control • • • • • Employee Training • • • • • Enterprise Risk Management • • • • • Failure Mode and Effects Analysis (FMEA) • • • Hazard Analysis Critical Control Points (HACCP) • Incidents, Accidents and Safety Reporting • • Job Safety Analysis (JSA) • • Legislative and Regulatory Requirements • • • • • Material Returns • • • Meetings Management • • • • • Monitoring and Inspection • • MSDS • • Nonconforming Materials • • • Product Specification Management • • • Production Part Approval Process (PPAP) • • Project Control • • • • • Quality Records Management • • • • • Receiving and Inspection • • • Supplier Rating • • • • Sustainability •

• 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

Document Control Change Management

Corrective Action Employee Training

Audits Deviations

Incidents, Accidents and Safety Reporting Meetings

Aspects, Objectives and Targets MSDS

Job Safety Analysis Calibration & Maintenance

Emergency Preparedness Legislative and Regulatory Requirements

Monitoring and Inspection Project Control

Risk/Hazard Register Quality Records

What We Offer

Centralized Reporting EtQ Designer

Alerts and KPI Reporting Connection Profiles (Integration)

Quantitative Risk Assessment Escalation/Delegation

Enterprise Configuration Center

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:




Audits Deviations

Nonconformances Meetings

Supplier Management FMEA

PPAP Calibration & Maintenance

PDM (Spec. Mgmt) Legislative and Regulatory Requirements

Complaint Handling Project Control

Material Returns Quality Records

What We Offer




Enterprise Configuration Center Suppliers & Materials


• Good Manufacturing Practices– Comprehensive integrated suite of modules built on the EtQ

Reliance Platform to meet the needs of GMP standards and initiatives:


Document Control Complaint Handling

Corrective Action Change Management

Audits Employee Training

Nonconformances Deviations

Supplier Management FMEA

PPAP Calibration & Maintenance



Material Returns Quality Records

What We Offer




Enterprise Configuration Center Electronic Signature (21 CFR Part 11)


• 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:




Audits Deviations

Nonconformances Meetings

Supplier Management Quality Records

HACCP Calibration & Maintenance



Material Returns

What We Offer






• 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:




Audits Deviations

Incidents, Accidents and Safety Reporting Meetings

FMEA MSDS

Job Safety Analysis Calibration & Maintenance

Emergency Preparedness Legislative and Regulatory Requirements

Monitoring and Inspection Project Control

Risk/Hazard Register Quality Records

What We Offer






Customer Benefits through EtQ

Time Savings Case in Point: Customers save time using EtQ

Reduced review periods from 45 days to 1 dayAverage 650 man hour savings each year

Report generation time reduced by 70% using EtQ

Enhanced Efficiency Case in Point: Processes are streamlinedReduced administrative overhead by 80% using EtQ’s tools

Reduced over 700 Redundant IT systems into 1 = EtQ!

Increased disposition efficiency using EtQ, representing over $25,000 in savings

Cost Savings Cases: Customers Maximize their investment in EtQ and see results!Saved over $250K upfront and $150K in maintenance by updating manual system to EtQ

Automatic Nonconformance process has freed up 3 full time resources for the company

By reducing time to search for records, EtQ’s system has saved $70,000 annually

EtQ RelianceTM

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.“

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 UtilitiesDesigner | Integration | Centralized Reporting | Quantitative Risk Assessment

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

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

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

Integrated Solution

EtQ Designer: Forms

EtQ Reliance Designer

EtQ Designer: Workflow

EtQ Designer: Views

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

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

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)

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

Centralized Reporting:

• Multi-Level Drill-Down Reporting

What is the breakdown on ABC?

LEVEL 2

What did it cost for each product line?

LEVEL 1

... just “click”

Centralized Reporting: Centralized Reporting:

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

Demonstration


EtQ Professional Services Model

Project Management Paradigm

Expected Resource Levelwith EtQ Implementation Process

Actual or Unplanned Resource

Level

Avoid Post ReleaseProblems

Traditional Resource Level

Time

Res

ou

rce

Lev

el

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

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.

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.

SIPOC Overview

SIPOC Overview

S I P O C

EventProblem Desc. (What, how do you know? Initial Information What is wrong? Mfg. Facility (internal/external)

Complaint Lot # Supplier Contact(s) ProcurementAudit Product Code Quantity Material SupplierMgmt. Review Quantity Status of issue Research & Engineering Material OwnersMfg. Facility (internal/external) Date of Problem Product #, Lot #(s) Raw Material Spec ownersProcurement Immediate Action Location Regulatory Agency (rare)Material Supplier Initial Impact Traceability - where is it? PlannersResearch & Engineering Material Owners Reporter Impact Material Coordinator / HandlerRaw Material Spec owners Where? Cost! Machine OperatorPlanners Actions takenMaterial Coordinator / Handler Assignee Review/Risk Assessment Authorizers/ApproversMachine Operator Historical Data Supplier ResponseRegulatory Agency (rare) Risk Assessment Comp. DispositionIncoming QA Cost EscalationsInspection Effect on scheduleFinished Product Testing PriorityProcess Upset

Begginning & end of problem Initial ContainmentSAP Item #SAP Lot #Key prod identifiersLocation(s)

Sample Information Investigation/Root CauseSupporting Attachments/Evidence (COA, MSDS, Photos, etc)InterviewsAnalysis - inv. Root causeIdentify Actions/Assignees

Identified Actions, assignees, due dates Take Actions

Actions Status Close out/ReviewDesired ActionsResult of the Action

Process Mapping

Word Form Mock-up

Visio Workflow Mock-ups

Detailed Design Specifications

Project Plan Overview


ISO 9001 System Certifications

For more info on

[email protected]

confidential: this document contains information that is confidential and proprietary to etq, inc....

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