EtQ for Medical Devices

In the highly competitive Medical Device market, only the most innovative andcost-effective products will survive. Success in this industry requires adherence toapplicable FDA regulations (such as 21 CFR 820 and 21 CFR Part 11), and may alsoinvolve meeting ISO standard requirements (such as ISO 13485:2003). Rapidproduct development processes providing responsiveness to changing marketdemands are key to meeting the demands of this market.

Device Manufacturers are challenged with maintaining quality systems that canadapt to the changing market needs, provide tools to shorten product developmentlifecycles, manage the supply chain, and are compliant with a wide range ofregulatory requirements.

Challenges facing the Medical Device MarketCollaborative, Enterprise EnvironmentLarge companies with multiple divisions often have independent, hybrid systemsin place. Bridging the gap between these systems is inefficient in the long-term,and ultimately will require expensive customization to link the enterprise.Meetings to discuss integration strategy and IT man-hours for customization canresult in lost time and money. EtQ's system is designed to incorporate the wholebusiness in collaborating at the enterprise level, while maintaining eachdivision's independent business workflow. The result is a unified system allowingeach division to collaborate with the enterprise.

Unified CAPA ProcessToo often, business processes are disconnected, with complaints, Nonconformingmaterial reports and other events are not integrated nor connected to externalbusiness systems. EtQ's system for Medical Device allows the process to belinked, automatically and intelligently. Complaint forms are assessed andinvestigated, and opened as a CAPA if needed. Risk Management tools assess therisk throughout the process. Documents are linked to the Training database, andassignments are sent for effective change management. This unified process formanaging events result in an efficient system, where no time is lost and no problemoverlooked.

Contract ManufacturingAs more companies rely on Contract Manufacturers to help bring their products to

market, it is important that the systems implemented allow for increased visibilitydownstream. EtQ provides integration at multiple levels of the process, allowing contract

manufacturers to take part in the overall business process, without direct access to themain system. This allows the Contract Manufacturers to fill in their pieces of the process,

and provide a seamless quality system, from start to finish.

ValidationAs required by 21 CFR Part 11, a secure environment must be maintained, and the systemmust be validated to maintain electronic signature integrity. As a result, validation servicescan double, or even triple the cost of a software system. EtQ's web-based system is designedspecifically for the Medical Device and Life Science industries, and our staff has developedthe test scripts necessary to ease system validation. Because the EtQ software is usableright out of the box and configurations are executed at the server level, the need forextensive validation across the enterprise is less than comparative systems in the market.

EtQ for Medical Devices

Integrated Quality SystemEtQ Medical Device is an integrated quality and compliance management system that has been pre-configured to specifically address theneeds of the Medical Device industry, and exceed 21 CFR Part 11 requirements. EtQ's unique modular approach provides unparalleled flexi-bility and automation. The modules are tightly integrated to deliver a best-in-class CAPA solution.

Connected to the Production SystemsEtQ Connectors close the gap between production systems and the quality system. Modules like NCM and Complaints connect to ERP andCRM systems to fully automate the creation and assignment of events. Production systems can then be automatically updated throughoutthe event resolution process. For example, to trigger the release of product based on the MRB disposition; or update the complaint statusbased on the investigation results.

Advanced Filtering of Events (Risk Assessment)EtQ’s Risk Assessment module can be used as a stand-alone tool, and isintegrated with EtQ’s modules. For example, EtQ's unique CAPA system isdesigned to minimize the number of CAPAs using an advanced filtering model:

• Automatic segregation and categorization of events at the source• Automatic identification and display of related events• Initial assessment to allow early closure• Risk assessment throughout the process to guide decision making• Full investigation with step-by-step root cause analysis• Automatic lookup and display of related investigations and CAPAs• Comprehensive CAPA action and effectiveness check plan with risk

mitigation history

Closed-Loop CAPAThe EtQ Reliance for Medical Device CAPA system is pre-configured to initiate various post-CAPA processes, including electronic distributionof CAPA results, Change Management, and Employee Training.

21 CFR Part 11 Compliance:EtQ features full compliance to 21 CFR Part 11, Electronic Signatures and Records, including:Electronic Signature Binding: EtQ automatically and securely binds the authenticated user's electronic signature. EtQ ensures that theuser has signed onto the system and exposed their signature via the forced authentication process. Authentication is required each time adocument is processed.

Audit Trail: EtQ securely and automatically posts any and all field changes to a separate database. The audit trail includes the field’s oldvalue, new value, name of user who made the change and date and time.

Controlled / Secure Access: EtQ’s robust security model ensures your system and data have the highest security. Information access iscontrolled by username, id, password, form, form section, field, and workflow.

Enhanced Password Security: Automatic password aging with configurable expiration and warning periods, as well as automatic protectionagainst repeated attempts to log in without proper username and password.

eValidationFor companies regulated by the Food and Drug Administration (FDA), systems validation is a necessary requirementto ensure a secure environment. The process of validation an enterprise system is often long and time consuming,and can take months, if not a whole year to compile and run.

The eValidator is a comprehensive set of commands that, when executed, will run validation test scripts automati-cally, and generate a full report of the results of this script. Using eValidator to automate the validation process will cut a company's validationtime by as much as 400% - a 4 day validation project can be done in less than a day using EtQ's eValidator.

Making Compliance a Competitive Advantage

EtQ is the leading Enterprise Quality and ComplianceManagement Software for identifying, mitigating andpreventing high-risk events through integration, automationand collaboration.

EtQ uses best in class integrated modules and enterpriseapplication integration to manage and measure quality andcompliance processes and execute organizational change.

eValidator

[Risk Tables in the EtQ Risk Assessment module]

EtQ Risk Table

[The EtQ Integrated System for Medical Device]

EtQ for Medical Devices

Complaint HandlingComplaint Handling manages the investigation and resolution of customer complaintsin compliance with FDA guidelines. It records all complaints reported by customersand/or consumers to investigate the problems, keeps records of these complaintsincluding information about the customers and the products. This database also providesan electronic MedWatch form, with electronic submissions to the FDA(eMDR).Key Features:• Automatic creation of complaints from 3rd party CRM systems (e.g SAP, Oracle)• Integrate with MS Office to create templates for various types of correspondence• Decision trees are configured out of the box (e.g MDR, ADI)• Many regulatory reporting forms (e.g MedWatch, MHRA, MedSafe)• Electronic submission to the FDA via EtQ eMDR Submission Tool• Use Risk Assessment Module to help guide decision making• Automatically inherit and link complaint data into CAPA investigation

NonconformanceDue to varying product offerings and customer needs, out of specification conditions canhave a variety of dispositions. You will be able to manage all steps in the nonconfor-mance process. Users can generate corrective actions and other workflows that link rightto the original nonconformance.Key Features:• Record all relevant product information• Integrate with ERP to automatically create NCMs• Automatically update product status in MRP based on NCM status (e.g Hold, Release)• Quality Alerts can be setup to automatically monitor repeated NCMs• Automatically notify MRB (Material Review Board)• Two, three or four dimensional risk assessment tables available out of the box• Automated guidelines/instructions based on calculated risk level• Built-in risk mitigation history• NCM data will be automatically inherited and linked into CAPA investigation

Corrective/Preventive Action (CAPA)Generate a Corrective Action or Preventive Action request that routesthrough review, root cause, corrective action taken, and verificationstages. Multiple reports are generated automatically providing aneffective mechanism for tracking the source and costs of problems.Key Features:• Active filtration minimizes number of investigations & optimizes the use

of resources• Initiate investigations for confirmed adverse events• Define investigation activities and assignments• Optionally route investigation plan for review and approval• Relevant data is automatically inherited (NCMR, Calibration, Audits, etc.)• Dual link between investigation and source application• Risk tool measures and tracks risk mitigation• Automatically lookup and display related investigations• Initiate CAPA plan for confirmed investigations• Define entire CAPA plan in one simple intuitive table format• CAPA plan includes individual, group or role assignments• CAPA plan automatically tracks progress and deliverables• Automatic notification of competed assignments• Automatic assignments & notifications for CAPA verification• Show risk mitigation history• PDF record of the complete CAPA history & related activities

DeviationThis database is designed to manage the Deviation process. You will beable to identify deviations, develop a deviation plan with targetcompletion dates, approve proposed deviations, and verify thecompletion of deviations that are in process.

Change ManagementEtQ Solutions Change Management module can be installed andmaintained easily with no special "technical" knowledge or dedicated ITresources. This module comes complete with the forms, queries, reportsand workflow already defined and ready to use. EtQ Solutions FlexibleWorkflow engine makes it easy to link to existing product data and pull itinto a change control form.

Risk AssessmentThe Risk Assessment module calculates risk using a variety oftechniques, updates risk at multiple points in the process, and displaysrisk mitigation history by event. Features the ability to integrate risk tableswithin all of EtQ’s modules, as well as risk charts to identify key riskindicators.

Delegation/EscalationDelegation is designed and developed to automate the process ofdelegating assignments. Delegation of assignments is typically usedwhen users are out of the office and would like to have theirassignments automatically routed to their delegates.

The Escalation database is designed to monitor date fields (i.e., duedates or review dates, etc.) that you define within every database. Itautomatically notifies personnel when assignments are due andoverdue.

Material ReturnsMaterial Returns design and track all returns that happen within yourcompany. This database allows you to identify, and track different typesof returns, the reason for the return, the material that needs to bereturned, and quantities to be returned. Users can generatenonconformances and other workflows that link right to the originalreturn.

Integrated Quality System For Medical Device

Document ControlDocument control manages the creation, approval, distribution andarchiving of all controlled documents. It is ready-to-use for such docu-ment types as manuals, procedures, work instructions, forms, jobdescriptions, and much more. Additional document types and tem-plates for each document type can be added without programming.You can even use your current documents that are in any MS Officeapplication (i.e., MS Word).Key Features:• Central repository for controlled documents• Linking related documents together• Reference documents from other EtQ modules• Integration with Microsoft Office synchronizes revision and approval

information automatically• Integrate with 3rd party document repositories(e.g OpenText,

Documentum, etc.)• Automatic sequential numbering with dynamic prefix and suffix• Multiple routing options: Parallel, Sequential, Voting• Electronic distribution of released documents• Record and display electronic signature of approvers• Automatic conversion to PDF• Hard copy distribution tracking• Full integration with EtQ's Training application• Satisfy training requirements by self-training or by automated testing• Automate the periodic review of released documents• Change request approval process• Change request on multiple related documents at once• Automatic archiving of old revisions• Restore archived documents

EtQ Centralized ReportingConsists of three tools to help you gather and report on data. TheRollup Tool allows you to pull data from multiple applications, in order togenerate global reports. With EtQ Charter Tool you can take data fromany database and present it in a spreadsheet and/or text format with agraph presented in Microsoft Excel. Quality Alerts is a special kind ofexception report that automatically notifies specific individuals ofrecurring events that you define.

Employee TrainingManage the identification, responsibilities, authorities, training andcertification requirements for each employee in an easy-to-useenvironment. Key Features:• Employee profiles contain all relevant employee information• Import and synchronize with existing systems• Employee groups based on Job Position and user definable groups• Synchronization of training requirements from Document Control • Create course profiles for repeated training• Automatic notification of invitees for scheduled or cancelled courses• Define pass/fail criteria and generate automated testing• Handles Ad -Hoc and OJT type training• Identify employee training/trainers by requirement, group or course • Allow trainees to perform course evaluations• Generate complete employee training reports

ArchiveThis database is a repository for archived documents from the otherdatabases.

Quality RecordsThis database documents quality records location, retention period,responsibility, indexing, disposition intervals and more.

AuditsThis database automates the process of auditing, including internal, vendor, customer and FDAaudits. All features of each audit type can be configured without programming.Key Features:• Build checklists for many audit types (Internal, Vendor, Customer, and FDA Audits)• Choose from a number of scoring options• Many ready to use checklists for ISO 9000, ISO 13485, ISO 14000, FDA and more• Automatic audit plan assignments once the audit plan has been approved• Issue audit report including completed checklists and related action items• Perform risk assessment using two, three or four dimensions on audit findings• Issue CAPA investigation based on audit findings• Inherit audit data into CAPA form - dual link between Audit and CAPA documentsCalibration & MaintenanceSchedule and record the results of all your calibration activities and costs. Each piece of equip-ment can be scheduled independently and easy-to-read reports and automatic notifications indi-cate when equipment is due for calibration. Record and track equipment that requires preventa-tive and reactive maintenance.Key Features:• Device profile includes all device information (e.g. manufacturer info, usage area(s), etc.)• Identify and track replacement parts• Automatic e-mail notification when replacement parts threshold is reached• Perform and record gauge R&R studies• Automatically create and assign work orders• Show traceability to NIST or other standards• Issue calibration certificates• Replacement parts are automatically deducted from inventory• Automatically flag equipment found to be out of calibration• Inherit calibration data into investigation -dual link between calibration & investigationMeetingsUse this database to plan meetings, schedule meetings, distribute the agenda, record minutes,assign action items and corrective action requests.

EtQ for Medical Devices

EtQ DesignerEtQ has made configuration easier than ever with EtQ Designer. EtQ Designer is an intuitive, graphical drag-and-drop interface for creating andmodifying workflows, forms, fields, and reports. As a result, it takes much less time to learn how to perform configurations and configurations canbe performed much faster. Some major features of the EtQ Designer include:

EtQ Workflow Builder: Build & modify workflows by dragging and dropping phases into a graphical representation of the workflow. Links betweenphases are automatically created. Access workflow & phase settings by simply clicking on the appropriate object.

EtQ Form Builder: Create and modify forms by dragging and dropping fields, sections and sub forms into the graphical representation of theform. The field properties are automatically set based on the selected field type, and the database is automatically updated without the needfor defining complicated database attributes. Access form, field, section and sub form settings by simply clicking on the appropriate object.

EtQ ReportBuilder: Create and modify reports by dragging and dropping fields into the graphical representation of the report view. The datasource is automatically created based on the selected fields, without the need to write complicated database queries. Access report views andcolumn settings by simply clicking on the appropriate object.

EtQ PortalRecent market research has shown that managers need easy access toconsolidated information regarding quality and compliance information.

Recognizing this need, EtQ released the EtQ portal, which allows for therollup of enterprise data into a single, flexible management view. WithEtQ portal, managers will be able to track Key Performance Indicators(KPI's), Quality Alerts, open and past due records, Exception Reports,and the overall status of quality and compliance issues within anorganization.

Before EtQ portal, quality and compliance managers would need tosearch out the data in the system, whether within the application or bymeeting with their departments. With EtQ portal in place, managers areable to see a real time view of the entire quality system, and can identi-fy and address potential problems before they occur.

This kind of enterprise level reporting allows the Quality Manager tobecome a hero to the organization. Less quality problems means moreproductivity, and this affects the bottom line...all 'must-haves' for anyorganization.

With EtQ portal, users can view:• Key Performance Indicators (KPI)• My Assignments• Favorites: Documents, Reports, Applications, etc• Delegation and Escalation Assignments• Application Launcher• Drill-down Charts• Saved Reports

[EtQ Designer: FormBuilder] [EtQ Designer: WorkflowBuilder]

[The EtQ portal]

EtQ eMDR Submission Tool: Enables Medical Device Manufacturers to electronically submit Medical Device Reports (MDRs) to theFood and Drug Administration (FDA).

Integration Management: EtQ's Integration APIs are able to provide an enterprise quality management solution that integrates infor-mation silos, making timely coordination and communication easy to achieve and removing any information gatekeepers. This focusedintegration of information silos greatly improves productivity across the enterprise, and make crucial data immediately available to theresources that need it, when they need it.

EtQ Connector for SAP: The EtQ Connector for SAP enables direct calls to SAP BAPIs via the SAP Java API, or via third-party EAItools. Calls can be scheduled or event-driven. The API includes methods for establishing connections and handling SAP data structures.EtQ integrates with SAP to accelerate the transfer of quality data to and from SAP and to eliminate gaps in the quality system.

PDF Conversion: Automatically convert any file attachment, form or report in to Adobe PDF™ format.

MS Office Integration: EtQ Office Integrator is a set of functions that manages links between EtQ Web applications and MicrosoftOffice™. With those functions, users store document files in Web databases as attachments. Through EtQ Office Integrator, users canread, edit, preview, and update documents in familiar programs like Word, Excel, and Visio and have the data automatically integratedinto EtQ forms.

Drill-Down, Server-Side Charts: EtQ’s robust centralized reporting is complete with over 40 chart templates, out of the box. The EtQ Drill-down charting tool lets you click areas on the chart to filter the information, and opens other sub-charts or the underlying view, with the documentsautomatically filtered by the selected value(s).

Features & Utilities

TOMCAT

medicaldevice

pharmaceutical

manufacturing

health&safety

Supported Systems

Supported Application ServersApache Tomcat 4.1.29, 5.0.18 IBM Websphere Application Server 6.0 BEA WebLogic v8.1, v9.2 Oracle Server 10g Release 3 (10.1.3)

Supported DatabasesMicrosoft SQL Server 2000 sp4, 2005 Oracle 9i, 10g MySQL 4.0.17, 5.0.22 DB2 v8.1

What did it cost foreach product line? Which departments

contributed to cost?Let me see the costdetails.

Let me open theoriginal documentrecord

EtQ’s flexible system architecture enables our customers to take advantage of EtQ'sQuality and Compliance systems, without having to change their IT infrastructure. Belowis a list of supported systems for the EtQ suite of products.*

*EtQ continually updates compatible systems, and this list may not reflect current system compatibility. For a detailedlist of compatible systems, and full system requirements, please visit us on the web at www.etq.com/sysreq/index.shtml

[EtQ Drill Down Reporting]

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EtQ Reliance is a trademark of EtQ, Inc. All other product names and company names are trademarks or registered trademarks of their respective owners. No endorsement of EtQ by suchcompanies is intended or implied. Copyright © 2007, EtQ, Inc.

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