EtQ for Medical Devices

Transcription

1

2 In the highly competitive Medical Device market, only the most innovative and cost-effective products will survive. Success in this industry requires adherence to applicable FDA regulations (such as 21 CFR 820 and 21 CFR art 11), and may also involve meeting ISO standard requirements (such as ISO 13485:2003). Rapid product development processes providing responsiveness to changing market demands are key to meeting the demands of this market. Device Manufacturers are challenged with maintaining quality systems that can adapt to the changing market needs, provide tools to shorten product development lifecycles, manage the supply chain, and are compliant with a wide range of regulatory requirements. Challenges facing the Medical Device Market Collaborative, Enterprise Environment Large companies with multiple divisions often have independent, hybrid systems in 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 can result in lost time and money. EtQ's system is designed to incorporate the whole business in collaborating at the enterprise level, while maintaining each division's independent business workflow. The result is a unified system allowing each division to collaborate with the enterprise. Unified CAA rocess Too often, business processes are disconnected, with complaints, Nonconforming material reports and other events are not integrated nor connected to external business systems. EtQ's system for Medical Device allows the process to be linked, automatically and intelligently. Complaint forms are assessed and investigated, and opened as a CAA if needed. Risk Management tools assess the risk throughout the process. Documents are linked to the Training database, and assignments are sent for effective change management. This unified process for managing events result in an efficient system, where no time is lost and no problem overlooked. Contract Manufacturing As more companies rely on Contract Manufacturers to help bring their products to market, it is important that the systems implemented allow for increased visibility downstream. EtQ provides integration at multiple levels of the process, allowing contract manufacturers to take part in the overall business process, without direct access to the main system. This allows the Contract Manufacturers to fill in their pieces of the process, and provide a seamless quality system, from start to finish. Validation As required by 21 CFR art 11, a secure environment must be maintained, and the system must be validated to maintain electronic signature integrity. As a result, validation services can double, or even triple the cost of a software system. EtQ's web-based system is designed specifically for the Medical Device and Life Science industries, and our staff has developed the test scripts necessary to ease system validation. Because the EtQ software is usable right out of the box and configurations are executed at the server level, the need for extensive validation across the enterprise is less than comparative systems in the market. EtQ is the leading Enterprise Quality and Compliance Management Software for identifying, mitigating and preventing high-risk events through integration, automation and collaboration. EtQ uses best in class integrated modules and enterprise application integration to manage and measure quality and compliance processes and execute organizational change. Making Compliance a Competitive Advantage Integrated Quality System EtQ Medical Device is an integrated quality and compliance management system that has been pre-configured to specifically address the needs of the Medical Device industry, and exceed 21 CFR art 11 requirements. EtQ's unique modular approach provides unparalleled flexibility and automation. The modules are tightly integrated to deliver a best-in-class CAA solution. Connected to the roduction Systems EtQ Connectors close the gap between production systems and the quality system. Modules like NCM and Complaints connect to ER and CRM systems to fully automate the creation and assignment of events. roduction systems can then be automatically updated throughout the event resolution process. For example, to trigger the release of product based on the MRB disposition; or update the complaint status based on the investigation results. Advanced Filtering of Events (Risk Assessment) EtQ s Risk Assessment module can be used as a stand-alone tool, and is integrated with EtQ s modules. For example, EtQ's unique CAA system is designed to minimize the number of CAAs 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 CAAs Comprehensive CAA action and effectiveness check plan with risk mitigation history [The EtQ Integrated System for Medical Device] [Risk Tables in the EtQ Risk Assessment module] Closed-Loop CAA The EtQ Reliance for Medical Device CAA system is pre-configured to initiate various post-caa processes, including electronic distribution of CAA results, Change Management, and Employee Training. 21 CFR art 11 Compliance: EtQ features full compliance to 21 CFR art 11, Electronic Signatures and Records, including: Electronic Signature Binding: EtQ automatically and securely binds the authenticated user's electronic signature. EtQ ensures that the user has signed onto the system and exposed their signature via the forced authentication process. Authentication is required each time a document 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 old value, 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 is controlled by username, id, password, form, form section, field, and workflow. Enhanced assword 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. evalidation For companies regulated by the Food and Drug Administration (FDA), systems validation is a necessary requirement to 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. EtQ Risk Table evalidator The evalidator is a comprehensive set of commands that, when executed, will run validation test scripts automatically, and generate a full report of the results of this script. Using evalidator to automate the validation process will cut a company's validation time by as much as 400% - a 4 day validation project can be done in less than a day using EtQ's evalidator.

3 Complaint Handling Complaint Handling manages the investigation and resolution of customer complaints in compliance with FDA guidelines. It records all complaints reported by customers and/or consumers to investigate the problems, keeps records of these complaints including information about the customers and the products. This database also provides an electronic MedWatch form, with electronic submissions to the FDA(eMDR). Automatic creation of complaints from 3rd party CRM systems (e.g SA, 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 CAA investigation Nonconformance Due to varying product offerings and customer needs, out of specification conditions can have a variety of dispositions. You will be able to manage all steps in the nonconformance process. Users can generate corrective actions and other workflows that link right to the original nonconformance. Record all relevant product information Integrate with ER to automatically create NCMs Automatically update product status in MR 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 CAA investigation Deviation This database is designed to manage the Deviation process. You will be able to identify deviations, develop a deviation plan with target completion dates, approve proposed deviations, and verify the completion of deviations that are in process. Change Management EtQ Solutions Change Management module can be installed and maintained easily with no special "technical" knowledge or dedicated IT resources. This module comes complete with the forms, queries, reports and workflow already defined and ready to use. EtQ Solutions Flexible Workflow engine makes it easy to link to existing product data and pull it into a change control form. Delegation/Escalation Delegation is designed and developed to automate the process of delegating assignments. Delegation of assignments is typically used when users are out of the office and would like to have their assignments automatically routed to their delegates. The Escalation database is designed to monitor date fields (i.e., due dates or review dates, etc.) that you define within every database. It automatically notifies personnel when assignments are due and overdue. Material Returns Material Returns design and track all returns that happen within your company. This database allows you to identify, and track different types of returns, the reason for the return, the material that needs to be returned, and quantities to be returned. Users can generate nonconformances and other workflows that link right to the original return. Corrective/reventive Action (CAA) Generate a Corrective Action or reventive Action request that routes through review, root cause, corrective action taken, and verification stages. Multiple reports are generated automatically providing an effective mechanism for tracking the source and costs of problems. 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 CAA plan for confirmed investigations Define entire CAA plan in one simple intuitive table format CAA plan includes individual, group or role assignments CAA plan automatically tracks progress and deliverables Automatic notification of competed assignments Automatic assignments & notifications for CAA verification Show risk mitigation history DF record of the complete CAA history & related activities Risk Assessment Integrated Quality System For Medical Device The Risk Assessment module calculates risk using a variety of techniques, updates risk at multiple points in the process, and displays risk mitigation history by event. Features the ability to integrate risk tables within all of EtQ s modules, as well as risk charts to identify key risk indicators. Document Control Audits Document control manages the creation, approval, distribution and archiving of all controlled documents. It is ready-to-use for such document types as manuals, procedures, work instructions, forms, job descriptions, and much more. Additional document types and templates for each document type can be added without programming. You can even use your current documents that are in any MS Office application (i.e., MS Word). 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: arallel, Sequential, Voting Electronic distribution of released documents Record and display electronic signature of approvers Automatic conversion to DF 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 This database automates the process of auditing, including internal, vendor, customer and FDA audits. All features of each audit type can be configured without programming. 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 erform risk assessment using two, three or four dimensions on audit findings Issue CAA investigation based on audit findings Inherit audit data into CAA form - dual link between Audit and CAA documents Calibration & Maintenance Schedule and record the results of all your calibration activities and costs. Each piece of equipment can be scheduled independently and easy-to-read reports and automatic notifications indicate when equipment is due for calibration. Record and track equipment that requires preventative and reactive maintenance. Device profile includes all device information (e.g. manufacturer info, usage area(s), etc.) Identify and track replacement parts Automatic notification when replacement parts threshold is reached erform 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 & investigation Meetings Use this database to plan meetings, schedule meetings, distribute the agenda, record minutes, assign action items and corrective action requests. Employee Training Manage the identification, responsibilities, authorities, training and certification requirements for each employee in an easy-to-use environment. Employee profiles contain all relevant employee information Import and synchronize with existing systems Employee groups based on Job osition 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 EtQ Centralized Reporting Consists of three tools to help you gather and report on data. The Rollup Tool allows you to pull data from multiple applications, in order to generate global reports. With EtQ Charter Tool you can take data from any database and present it in a spreadsheet and/or text format with a graph presented in Microsoft Excel. Quality Alerts is a special kind of exception report that automatically notifies specific individuals of recurring events that you define. Quality Records This database documents quality records location, retention period, responsibility, indexing, disposition intervals and more. Archive This database is a repository for archived documents from the other databases.

4 EtQ Designer EtQ has made configuration easier than ever with EtQ Designer. EtQ Designer is an intuitive, graphical drag-and-drop interface for creating and modifying workflows, forms, fields, and reports. As a result, it takes much less time to learn how to perform configurations and configurations can be 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 between phases 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 the form. The field properties are automatically set based on the selected field type, and the database is automatically updated without the need for 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 data source is automatically created based on the selected fields, without the need to write complicated database queries. Access report views and column settings by simply clicking on the appropriate object. Features & Utilities EtQ emdr Submission Tool: Enables Medical Device Manufacturers to electronically submit Medical Device Reports (MDRs) to the Food and Drug Administration (FDA). Integration Management: EtQ's Integration AIs are able to provide an enterprise quality management solution that integrates information silos, making timely coordination and communication easy to achieve and removing any information gatekeepers. This focused integration of information silos greatly improves productivity across the enterprise, and make crucial data immediately available to the resources that need it, when they need it. EtQ Connector for SA: The EtQ Connector for SA enables direct calls to SA BAIs via the SA Java AI, or via third-party EAI tools. Calls can be scheduled or event-driven. The AI includes methods for establishing connections and handling SA data structures. EtQ integrates with SA to accelerate the transfer of quality data to and from SA and to eliminate gaps in the quality system. DF Conversion: Automatically convert any file attachment, form or report in to Adobe DF format. MS Office Integration: EtQ Office Integrator is a set of functions that manages links between EtQ Web applications and Microsoft Office. With those functions, users store document files in Web databases as attachments. Through EtQ Office Integrator, users can read, edit, preview, and update documents in familiar programs like Word, Excel, and Visio and have the data automatically integrated into 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 documents automatically filtered by the selected value(s). LEVEL 1 What did it cost for each product line? LEVEL 2 Which departments contributed to cost? LEVEL 3 Let me see the cost details. [EtQ Designer: FormBuilder] [EtQ Designer: WorkflowBuilder] EtQ ortal Recent market research has shown that managers need easy access to consolidated information regarding quality and compliance information. Recognizing this need, EtQ released the EtQ portal, which allows for the rollup of enterprise data into a single, flexible management view. With EtQ portal, managers will be able to track Key erformance Indicators (KI's), Quality Alerts, open and past due records, Exception Reports, and the overall status of quality and compliance issues within an organization. Before EtQ portal, quality and compliance managers would need to search out the data in the system, whether within the application or by meeting with their departments. With EtQ portal in place, managers are able to see a real time view of the entire quality system, and can identify and address potential problems before they occur. This kind of enterprise level reporting allows the Quality Manager to become a hero to the organization. Less quality problems means more productivity, and this affects the bottom line...all 'must-haves' for any organization. With EtQ portal, users can view: Key erformance Indicators (KI) My Assignments Favorites: Documents, Reports, Applications, etc Delegation and Escalation Assignments Application Launcher Drill-down Charts Saved Reports [The EtQ portal] Supported Systems EtQ s flexible system architecture enables our customers to take advantage of EtQ's Quality and Compliance systems, without having to change their IT infrastructure. Below is a list of supported systems for the EtQ suite of products.* Supported Application Servers Apache Tomcat , IBM Websphere Application Server 6.0 BEA WebLogic v8.1, v9.2 Oracle Server 10g Release 3 (10.1.3) Supported Databases Microsoft SQL Server 2000 sp4, 2005 Oracle 9i, 10g MySQL , DB2 v8.1 [EtQ Drill Down Reporting] *EtQ continually updates compatible systems, and this list may not reflect current system compatibility. For a detailed list of compatible systems, and full system requirements, please visit us on the web at LEVEL 4 Let me open the original document record TOMCAT

5 visit our website or call for a free demo w w w. e t q. c o m info@etq.com 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 such companies is intended or implied. Copyright 2007, EtQ, Inc.