Transcript Enterprise Quality Management Solution

Enterprise Compliance Management
Solution
Tim Fischer
EtQ Enterprise Account Executive
Tom Barlow
EtQ Pre-Sales Engineer
ISO Certifications
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.
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…
MMM, 3%
Pharmaceuticals, 6%
Technology, 6%
Other, 10%
Medical Device, 17%
Aerospace, 2%
Airlines, 5%
Manufacturing, 16%
Automotive, 3%
Biotechnology, 5%
Chemicals, 5%
Consumer Goods, 3%
Food & Beverage, 10%
Electronics, 5%
Government, 3%
Energy, 4%
Customer-Centric Company
• Install base
– Over 500 companies
– Over 1,000,000 users to date
– Across 4000+ sites
Module Breakdown
For more details:
ETQ
Online Modules Matrix
www.etq.com/modules/matrix.shtml
Module Breakdown
Modules - As of version 10.0 of EtQ Reliance:
Audits 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
QMS
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GMP
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EHS
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F&B
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SMS
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What We Offer
• Environmental Health and Safety
http://www.etq.com/modules/matrix.shtml
– Comprehensive integrated suite of modules built on the EtQ
Reliance Platform to meet the needs of EH&S Management
standards and initiatives:
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
– Features comprehensive set of utilities
Centralized Reporting
EtQ Designer
Alerts and KPI Reporting
Connection Profiles (Integration)
Quantitative Risk Assessment
Escalation/Delegation
Enterprise Configuration Center
What We Offer
• Quality Management Solution
http://www.etq.com/modules/matrix.shtml
– Comprehensive integrated suite of modules built on the EtQ
Reliance Platform to meet the needs of Quality Management
standards and initiatives:
Document Control
Change Management
Corrective Action
Employee Training
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
– Features comprehensive set of utilities
Centralized Reporting
EtQ Designer
Alerts and KPI Reporting
Connection Profiles (Integration)
Quantitative Risk Assessment
Escalation/Delegation
Enterprise Configuration Center
Suppliers & Materials
What We Offer
• Good Manufacturing Practices
http://www.etq.com/modules/matrix.shtml
– 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
PDM (Spec. Mgmt)
Legislative and Regulatory Requirements
Complaint Handling
Project Control
Material Returns
Quality Records
– Features comprehensive set of utilities
Centralized Reporting
EtQ Designer
Alerts and KPI Reporting
Connection Profiles (Integration)
Quantitative Risk Assessment
Escalation/Delegation
Enterprise Configuration Center
Electronic Signature (21 CFR Part 11)
What We Offer
• Food Safety Management Solution
http://www.etq.com/modules/matrix.shtml
– Comprehensive integrated suite of modules built on the EtQ
Reliance Platform to meet the needs of Food Safety standards
and initiatives:
Document Control
Change Management
Corrective Action
Employee Training
Audits
Deviations
Nonconformances
Meetings
Supplier Management
Quality Records
HACCP
Calibration & Maintenance
PDM (Spec. Mgmt)
Legislative and Regulatory Requirements
Complaint Handling
Project Control
Material Returns
– Features comprehensive set of utilities
Centralized Reporting
EtQ Designer
Alerts and KPI Reporting
Connection Profiles (Integration)
Quantitative Risk Assessment
Escalation/Delegation
Enterprise Configuration Center
What We Offer
• Aviation Safety Management Solution
http://www.etq.com/modules/matrix.shtml
– Comprehensive integrated suite of modules built on the EtQ
Reliance Platform to meet the needs of Aviation Safety
Management standards and initiatives:
Document Control
Change Management
Corrective Action
Employee Training
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
– Features comprehensive set of utilities
Centralized Reporting
EtQ Designer
Alerts and KPI Reporting
Connection Profiles (Integration)
Quantitative Risk Assessment
Escalation/Delegation
Enterprise Configuration Center
Customer Benefits through EtQ
Time Savings Case in Point: Customers save time using EtQ
Reduced review periods from 45 days to 1 day
Average 650 man hour savings each year
Report generation time reduced by 70% using EtQ
Enhanced Efficiency Case in Point: Processes are streamlined
Reduced 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
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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
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
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Language Preference
– Each user can specify their preferred language based upon browser settings
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Local Date and Number Format
– Dates, times and numbers are automatically displayed and captured in the
user's local format
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Double-byte Character Support
– EtQ Reliance also supports Double-Byte Character
Set (DBCS) such as Japanese, Chinese and Korean
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Multi-Language Global Roll-up Reporting
– Keyword fields store their values as unique ID code
to allow global roll-up reporting across multiple
regardless of the language used to
select the values
languages,
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 Reliance Designer
EtQ Designer: Workflow
EtQ Designer: Forms
EtQ Designer: Views
Timeliness, Efficiency and Accountability
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Email
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Escalations
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Automated reminders involving others if necessary
Delegation
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Immediate Assignment and Notification
Assign review and approval duties to a delegate
Electronic Signatures
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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
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Create synchronized MS Office attachments
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Synchronize Word and Excel attachments
Synchronize MS Project files with Reliance Projects
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Publish to MS SharePoint
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Synchronize Users and Groups from Directory Services
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SAP Certified Integration
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Provide links to External URLs
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Real time JDBC lookups from external systems
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Configurable Connection Profile
– Delimited Text, JDBC/JNDI or XML
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Full Featured API
EtQ APIs:
(Java, XML, Web
Services)
Table
(Data Repository)
EtQ APIs:
(Java, XML,
Web Services)
Centralized Reporting:
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Multiple formats
Scheduled, ad-hoc, portal
Search, filter tools
Export to Excel, PDF
Use 3rd party tools
Centralized
Reporting:
Centralized
Reporting:
• Multi-Level Drill-Down Reporting ... just “click”
LEVEL 1
What did it cost for
each product line?
LEVEL 2
What is the
breakdown on ABC?
EtQ RelianceTM Summary
• A fully automated, configurable
workflow-based business
process automation tool
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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
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.
Project Management Paradigm
Expected Resource Level
with EtQ Implementation Process
Traditional Resource Level
Avoid Post Release
Problems
Actual or
Unplanned
Resource
Level
Time
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
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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):
system.
Responsible for providing online technical support for the
Project Roles and Responsibilities
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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
Event
Complaint
Audit
Mgmt. Review
Mfg. Facility (internal/external)
Procurement
Material Supplier
Research & Engineering Material
Owners
Raw Material Spec owners
Planners
Material Coordinator / Handler
Machine Operator
Regulatory Agency (rare)
Incoming QA
Inspection
Finished Product Testing
Process Upset
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Problem Desc. (What, how do you
know?
Lot #
Product Code
Quantity
Date of Problem
Immediate Action
Initial Impact
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Initial Information
Reporter
Where?
Assignee
Historical Data
Risk Assessment Comp.
Cost
Effect on schedule
Priority
Review/Risk Assessment
Begginning & end of problem
SAP Item #
SAP Lot #
Key prod identifiers
Location(s)
Initial Containment
Sample Information
Supporting Attachments/Evidence
(COA, MSDS, Photos, etc)
Interviews
Analysis - inv. Root cause
Identify Actions/Assignees
Investigation/Root Cause
Identified Actions, assignees, due
dates
Actions Status
Desired Actions
Result of the Action
Take Actions
Close out/Review
O
C
What is wrong?
Supplier Contact(s)
Quantity
Status of issue
Product #, Lot #(s)
Location
Traceability - where is it?
Mfg. Facility (internal/external)
Procurement
Material Supplier
Research & Engineering Material Owners
Raw Material Spec owners
Regulatory Agency (rare)
Planners
Impact
Cost!
Actions taken
Authorizers/Approvers
Supplier Response
Disposition
Escalations
Material Coordinator / Handler
Machine Operator
Process Mapping
Word Form Mock-up
Visio Workflow Mock-ups
Detailed Design Specifications
Project Plan Overview
For more info on
www.etq.com
blog.etq.com
[email protected]
800-354-4476
ISO 9001 System Certifications
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.