Medical Device Solution

Transcription

1 Medical Device Solution How to Achieve FDA 21 Part 820 Compliance With Polarion Europe, Middle-East, Africa: Polarion Software GmbH Lautlinger Weg Stuttgart, GERMANY Tel Fax info@polarion.com Americas & Asia-Pacific: Polarion Software, Inc. 406 Tideway Dr. Alameda, CA 94501, USA Tel (Toll free) or Fax info@polarion.com

2 FDA 21 Part 820 In many ways medical device manufacturers represent the most advanced form of mechatronics by combining Mechanical engineering, Electronic engineering, Computer engineering, Software engineering, Control engineering, and Systems Design engineering in order to design, and manufacture useful safe products. As you can see from the large and growing list of medical device manufacturers that have standardized on Polarion, our customers are engineering operations creating and managing products and systems, with a high degree of embedded software; and/or highly regulated and compliance-driven operations where risk management and accountability are driving business forces in building products and systems. For relatively complex medical device, the time between initiation of development and approved release to market typically takes about five years. To this period add another minimum five to ten years of maintaining the device in the market. During the lifecycle of the device, project requirements will change, variations will be manufactured, and employees, partners, and contractors will be in constant flux. For example, the FDA s analysis of medical device recalls due to software failures reveals that 79% were caused by software defects that were introduced when changes were made after its initial production and distribution. To safeguard the population and provide guidance to manufacturers, the U.S. Food and Drug Administration (FDA) established FDA 21 Part 820 as a basic set of quality system regulations for pharmaceutical products and medical devices to ensure that their products consistently meet applicable requirements and specifications. FDA 21 Part 820 does not regulate how a medical device manufacturer must produce their products. Rather, the regulation acknowledges international quality standards such as ISO and defines the framework and elements that must be present in a quality system. FDA 21 Part 820 regulation affects all medical device manufacturers who produce any finished product intended for human physical use, whether at the design, production or packaging stage. All components, and their respective lifecycles, included in any finished products are overseen by this regulation, and must adhere to the quality standards laid out by the FDA. In other words, if the medical device manufacturer includes third party components as part of the finished product, those OEM or outsourced components must comply with FDA 21 Part 820 regulation. Polarion customers estimate that using Polarion software for FDA 21 Part 820 compliance provides the advantages to utilize smaller teams and deliver quicker results, with cost savings of between 35% to 50%.

3 Detailed Challenges I make finished Class II and Class III finished products. My products are a combination of third party components from US, Germany, and China, which I integrate and load with my proprietary embedded software. I understand that the third party (OEM) component suppliers are not encumbered by FDA 21 Part 820 regulation. My challenge is maintaining the Design Controls and Document Controls, and proving it during an audit to pass compliance. Each manufacturer shall establish and maintain a Design History File (DHF) for each device. The DHF contains or references all records, artifacts, work items, tasks, decisions, tests, approvals necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. Traditionally, medical device manufacturers have labored through this task with mountains of paper documents, or costly document management systems never in synch with the actual project, and never designed for the complexity of medical devices that involve software, hardware, systems, third parties, and distributed teams. Polarion customers enjoy requirements based lifecycle management, continuous integration of any and all elements. In minutes, Polarion customers create a DHF at a point in time, manage any number of DHF s, all with guaranteed traceability and the forensic level reports to satisfy any audit. My company has a If it s not broke, don t fix it attitude. Many companies continue to manage their quality systems and risk assessment with paper based documents. There are huge inefficiencies with unacceptable costs and risks involved with paper based systems. Others have moved to electronic documents such MS Word spread across disparate servers, networks, and local devices, making it difficult to leverage data, change management is a nightmare and maintaining traceability impossible. Polarion customers enjoy full lifecycle seamless integration: As changes in requirements are made, or errors are detected, faults must be traced to the design and to ensure that compliance with regulations can be verified. In the event that product failures are experienced in the market, it is necessary to determine where that defect occurred, in what specific component, either in the original product design, during manufacturing, in clinical trials, or in post-market reuse or variance. With Polarion you have guaranteed traceability managed and maintained for the lifecycle of that product and each and every artifact and component linked to that product. Polarion customers reduce their costs associated with quality management systems, record keeping, risk management and audits by 80%.

4 We are new team with limited QA and no one in QA has worked with FDA 21 Part 820 before. Polarion customers range from small, medium, to Fortune 1000 all Polarion customers reduce their QA costs by 50-80% for FDA 21 Part 820 compliance. Quality management polices and SOPs are delivered out-of-the-box as templates to use or modify. Workflow driven solutions guarantee compliance to policies and SOPs. A common UI for all aspects of requirements, through design, development, testing and manufacturing enables users to easily adopt different roles and reduce outsourced resources. Limited budget for a solution. We need quality solution delivered yesterday at cheap prices, because we have no money until this product is FDA 21 Part 820 compliant. Weigh the risk your device presents against the regulations so you can achieve the right balance of compliance and business requirements. Polarion software is 80% less costly than most of competitors, the pricing is on our web site, for you to compare. Polarion implementations are completed in 8-10 days. Our customer loyalty and references are second to none due to our quality and professional services. I make finished Class II and Class III finished products. Can Polarion help with 510k approval by the FDA? Yes. Each manufacturer of any Class II or Class III device, and the Class I devices automated with computer software shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. Polarion s unique ability to seamlessly integrate all artifacts of the DHF and present the data in a document allows you to build the 510k premarket approval submission starting from inception of your project.

5 Can Polarion help me meet the FDA s Quality System Regulation requirements or ISO 13485, ISO and IEC 62304? Absolutely. The FDA s Quality System Regulations require an effective quality management system based on process-oriented structure and demand process-oriented observance by a business during implementation. Each manufacturer and their executive management are liable and responsible for adhering to the FDA 21 Part 820 regulations and for maintaining an effective quality management system, which includes quality policies commensurate with the level of risk associated with your product, SOPs (e.g. Issue Tracking, Requirements Approvals, Change Control, Testing, Device Recall etc.) which enforce your quality policies, and an organizational structure that supports the SOPs to achieve the quality needed for your desired level of risk management. Polarion customers enjoy a strong process-oriented continuous lifecycle development, which is amazingly efficient no additional steps are required to create live data quality management reports to pass any rigorous audit. With Polarion you do not waste time or defocus precious resources to create out-of-synch documents. Polarion automatically records each and every artifact or element of your project providing huge efficiencies to automatically generate the reports needed for ISO 13485, ISO and IEC or the FDA s Quality System Regulations. The use of Polarion during the FDA audit was, simply stated, incredible. The auditors all remarked that Polarion was impressive. Without printing a single a document or spending days preparing in advance we were able to easily and quickly show that all changes to our software and hardware were tracked tested and approved. Everything is linked and traceable. Polarion Customer

6 How to achieve FDA 21 CFR Part 820 compliance with Polarion 1. Security practices that limit access to authorized users and hold them accountable for their actions. Access is limited to authorized users by positively identifying user through a unique user name and password. This information is controlled and centrally managed via secure Polarion license server. Every single user change is recorded and immutable. 2. Polarion uses advanced analytics and reporting capabilities in the form of template and customized reports to help increase management oversight. Records can only be read or modified by users with security access and permissions established by administrator on project and/or global basis. 3. Configurable and secure workflow reduces cycle time by automating routing and approval and incorporating escalation for overdue tasks. Polarion workflow rules manage change and approval routing per your organization s process, ensuring only those users and/or only those electronic records with clearance, permission, or pre-requisites achieved are able to receive approval to progress. Work items or electronic records collaboration move along a pre-defined workflow, from one department to the next. Overdue tasks, bottlenecks, resource issues automatically escalate in real time status project plans and notifications.

7 4. Automatic document control for revisions to ensure that only the current version of a standard operating procedure is available Full and immutable change history is recorded for each and every electronic record change/approval, with side by side compare, and full search and query for audit report generation. 5. The username and password used at login positively, and undeniably, identifies the user. After login, changes and approvals are authenticated using electronic signatures. 6. Accurate traceability maintained for all electronic records, throughout the entire lifecycle, including electronic signatures used for changes and approvals.

8 7. Polarion s import-export round trip with MS Office is light years beyond all competitors for document control, version management, issue tracking, ease of use and fast adoption. 8. Polarion s management of electronic records is second to none. Electronic signatures for whatever process, artifacts, work items, or documents you choose are completely automated. 9. Polarion uniquely integrates and manages any electronic record, document type, or format from CAD through UML to MS Office, regardless of the software used to create them.

9 10. Polarion is Web-based so that it can connect all employees, partners, suppliers involved from virtually anywhere. Polarion provides a centralized repository for easy access and collaboration by all authorized users. Polarion also provides off-line clients at no additional charge! 11. Polarion is totally open via API and Web Services. Please check out the POP ( polarion.com) site to see examples of how easy it is for Polarion customers to integrate with any third party application or create their own extensions and customizations. 12. Polarion out of the box provides industry proven processes to get you going fast. These templates and modules may be reused, customized or used as examples to create your own. There is a powerful template for IEC compliance on the POP site (

10 13. Polarion s award winning Lucene on steroids hybrid search engine is part of all our products. A search window is available throughout the application. All reports may be saved on a project or global basis for others to use. visit /products/medical/ for more information Partners These partner companies have contributed their knowledge and expertise in the field of medical device development and standards. They have done the legwork, so you don t have to: Customers Here are a few examples of our customers in the Medical Devices, Biotechnology and Pharmaceuticals sectors: Did You Know? Polarion Software s integrated ALM solutions manage requirements engineering, team collaboration, bug tracking, version control, CMMI compliance, Agile process, and more for many kinds of projects with over 1,000,000 users world-wide in broad range of industries. Europe, Middle-East, Africa: Polarion Software GmbH Lautlinger Weg Stuttgart, GERMANY Tel Fax Polarion Software - info@polarion.com Americas & Asia-Pacific: Polarion Software, Inc. 406 Tideway Dr. Alameda, CA 94501, USA Tel (Toll free) or Fax info@polarion.com