Perforce user webinar fractyl dhb jb_dhb_adr edits
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From Word Docs to Compliance: How Fractyl Achieved CE Certification in Record Time Fractyl — a clinical-stage medical technology company — was founded in 2010 with the goal to combat insulin resistance and restore metabolic health. Twelve months ahead of schedule, they received a CE Mark for their innovative Revita™ procedure. So how did Fractyl achieve such rapid success? Compliance in a Flash Ann Rossi, Senior Software Quality Assurance Manager of Fractyl Laboratories, tells Fractyl’s incredible success story — and how Helix ALM helped the company achieve compliance 12 months earlier than they expected. Ann will share: • Fractyl’s problem-solving process. • Their struggles with Word and JIRA. • How Helix ALM played a vital role. Find out how Fractyl achieved compliance so quickly — and how you can, too.
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Perforce user webinar fractyl dhb jb_dhb_adr edits
- 1. From Word Docs to Compliance: How Fractyl Achieved CE Certification in Record Time Nico Kruger, Technical Solutions Engineer Perforce Software Ann Rossi, Sr. Software Quality Assurance Manager Fractyl Laboratories, Inc., Lexington MA
- 2. 2© Perforce Software Inc. All Rights Reserved. Presenters Nico Krüger Technical Solutions Engineer Ann Rossi Sr. Software Quality Assurance Manager
- 3. 3© Perforce Software Inc. All Rights Reserved. Introduction Fractyl is a clinical-stage medical technology company developing innovative procedures and devices to address insulin resistance and restore metabolic health.
- 4. 4© Perforce Software Inc. All Rights Reserved. • Fractyl has created the RevitaTM duodenal mucosal resurfacing (DMR) System, an investigational, minimally invasive, same-day clinical procedure. It’s designed to address the intestinal cause of insulin resistance and restore metabolic health in patients suffering from metabolic diseases, such as Type 2 Diabetes. Introduction Restore The lining of the duodenum Improve Insulin resistance and metabolic health Correct Abnormal hormonal signaling and nutrient absorption
- 5. 5© Perforce Software Inc. All Rights Reserved. Agenda 1 Medical Device Compliance Overview 2 Our Problem(s) to Solve 3 How we used Helix ALM to obtain Compliance with IEC 62304 (SW) 4 How we drove to compliance with FDA and ISO Medical Device Quality System Regulations (Including Risk Management)
- 6. 6© Perforce Software Inc. All Rights Reserved. • ISO 13485: International standard for medical device quality systems • FDA Quality System Regulation (QSR) • Based on ISO 13485 Medical Device Compliance ISO 13485:2003 and FDA Quality System Regulation
- 7. 7© Perforce Software Inc. All Rights Reserved. • IEC 62304: Software Life Cycle for Medical Devices • ISO 14971 Risk Management Medical Device Compliance
- 8. 8© Perforce Software Inc. All Rights Reserved. FDA Design Waterfall Process User Needs Design Input Development Process Design Output Design Output Validation Clinical Trials Verification Design Review
- 9. 9© Perforce Software Inc. All Rights Reserved. • We had the procedures to comply with the Quality Management System Regulations… • Product Development Procedure • Software Development and Maintenance Processes • Software Problem Resolution Procedure • Risk Management Procedure • BUT we needed an electronic system to simplify things. Procedures
- 10. 10© Perforce Software Inc. All Rights Reserved. • Many requirements that we needed to organize with unique identifiers. • We needed to comply with Medical Device Quality System Regulations (FDA and EU). • We needed to assure that we had traceability from the requirements to design verification tests, and associated issues. • Use of requirements traceability enables product development teams to attain a level of project control, quality assurance, and product safety that is difficult to achieve by any other means. The Problems to Solve (Immediate Needs)
- 11. 11© Perforce Software Inc. All Rights Reserved. Traceability “In the most common form of the traceability matrix, the input requirements are enumerated in a table, and references are provided to each section in the output documents (or software modules) which address or satisfy each input requirement.” - From the FDA
- 12. 12© Perforce Software Inc. All Rights Reserved. • Sample of what Regulatory Agencies are looking for… Trace Matrix
- 13. 13© Perforce Software Inc. All Rights Reserved. Traditional Trace Matrix
- 14. 14© Perforce Software Inc. All Rights Reserved. How to Find the Solution • Having continuous improvement through this problem solving process is best practice in any industry. Identify and Define the Problem Analyze the Problem Identify Possible Solutions Select and Plan the Solution Implement the Solution Evaluate the Solution Problem Solving
- 15. 15© Perforce Software Inc. All Rights Reserved. • We had requirements and tests in Word documents. • Software issues were in Jira; others were captured in Word documents. Where Our Quality System Started… No Easy Way to Trace
- 16. 16© Perforce Software Inc. All Rights Reserved. Helix ALM – Requirements Module
- 17. 17© Perforce Software Inc. All Rights Reserved. • Requirements by Release Developed a Folder Structure
- 18. 18© Perforce Software Inc. All Rights Reserved. Issues Module
- 19. 19© Perforce Software Inc. All Rights Reserved. Test Case / Test Runs
- 20. 20© Perforce Software Inc. All Rights Reserved. • We use this in our Verification Summary Report that is submitted to regulatory bodies. Software Trace Matrix (Direct from Helix ALM Reporting)
- 21. 21© Perforce Software Inc. All Rights Reserved. Hardware Team Jumped on the Bandwagon Design and development planning Design Verification Risk analysis and preventive action Design Validation Design process phases and reviews Design Inputs Customer Needs Design Outputs Product
- 22. 22© Perforce Software Inc. All Rights Reserved. Risk Management Compliance FMEA – Risk Management Tool
- 23. 23© Perforce Software Inc. All Rights Reserved. Helix ALM System Use SOP Helix ALM System Use SOP
- 24. 24© Perforce Software Inc. All Rights Reserved. • December 2010 • Fractyl began as a two person company. • August 2014 • Fractyl received ISO 13485 2003 Certification. • June 2016 • Fractyl received CE Mark. • September 2017 • Fractyl received ISO 13485 2016 Certification. Compliance Timeline
- 25. Questions? Thank you very much for your attendance!
- 26. Follow us for news and insights! Visit www.perforce.com
Editor's Notes
- About me, I have worked in SW Compliance for 20 plus years, starting in Financial Services, then last 8 years in Medical Device Software Compliance. I have been at Fractyl since 2013, when they had were a small start up of approximately 16 employees.
- Two awesome presenters…. - Nico Nico Kruger is a Technical Solutions Engineer for Perforce Software, specializing in technical guidance and product development efficiency for global organizations. With 15 years of software development expertise, Nico helps drive quality product strategy with Helix platform tools. - Ann Ann Rossi is the Senior Software Quality Assurance Manager at Fractyl Labs in Lexington, MA, where she has been employed for the past four years. Prior to her current position, she held various positions in Software Quality Assurance, Software Compliance, and Systems Analysis in corporate environments for over 25 years. Ann started in the financial services industry, and for the past eight years, has been involved in the medical device field.
- Currently approximately 60 employees at our office in Lexington, MA
- The Revita™ DMR procedure and device are currently being evaluated in clinical trials. We were founded in late 2010 and have grown from a 2 person to a 60 plus person company. See more information about our company and procedure at www.fractyl.com
- These are the two major bodies that regulate the medical device industry…ISO oversees, Europe, Canada, parts of Asia and Australia, FDA regulates Medical Device companies in the U.S. Recent updates to 13485 to 2016 – we were recently audited and received the 2016 certification. Not many companies have achieved this milestone yet.
- Two other major standards to comply with as a Medical Device Company – There are many other guidances and standards, they are all created for one reason – making sure medical devices are developed and tested safely so patients are safe – that’s the bottom line.
- Process from the FDA, as part of the good manufacturing practice requirements, but harmonized to ISO 13485.
- Too difficult to do comply with all of the requirements, tests, and issues found with a paper based system
- The FDA requires medical device companies to verify that all the design outputs meet the design inputs
- Using Excel, very difficult to maintain – manual process. Been there, done that.
- Years of working with project treams and then project manager for many Software System and application implementation and Software Quality Assurance, I have learned that having continuous improvement through this problem solving process is best practice in any industry.
- Everything was in manual documents and issues were in a system on their own – no way to link items, no way to show traceability!
- The Fractyl Software team led the way to implement the Helix ALM (formerly TestTrack) requirements module-we took baby steps but found our way with application services/support-starting with me attending an intensive Administrators’s course via Webinar. Then we started with the Requirements Module only to get our footing. Remember, at this point, we still were only a 17 person company.
- To organize our requirements we use the folder structure– By Release, by Component. In Compliance with 21 CFR Part 11, we added electronic signature component. Compliance feature in Admin tools could make this system compliant for electronic signatures, requiring a user name, password and reason.
- We added related issues found in the Software Release to the issues module, then we added them to the folder structure as well to organize them by release. Put workflows in place for testers and developers.
- Workflows were able to meet compliance by not being able to start at test run without full approval of the test case, the modules met full compliance of regulatory requirements by having expected and actual results, Pass and fail for each step, and for the overall test case. Approval workflows require the tester to approve first after the run of the test case (regulatory requirement) before routing to the others for post-run approval.
- Maintain through links, link each requirement to each associated test case, then each test case to a test run. Issues are usually linked as well. On left is how we configure the report-being able to pinpoint folders to point to the requirement, test case and test run set that we want to display – we can also add more detail to each of these columns (such as item description, approved by etc) but we choose not to add too much details, since the records can be viewed in Helix ALM.
- Design and development planning process With the current development of our commercial product, last spring, the product hardware development team started using Helix ALM for the commercial project. We reconfigured so all of our Engineering groups (Hardware –which includes catheter and console teams, and Software could use the same project. Revised our Issues workflows to have separate paths and attributes if item is SW or HW.
- Recently we are in the process of being in full compliance of our Risk Management Process through Helix ALM. (Compliance to ISO 14971 – last piece to our puzzle
- We had started our Helix ALM System Use SOP way back when we just had our first SW Project started (Requirements, Tests, Issues) our design inputs and outputs, now we are in the process of updating it to include our risk management analysis in TT.
- Add images for ISO 13485 and CE Mark Certificates. CE Mark allows us to declare that the product meets all the legal requirements for it to be sold in the European Union. We take our regulations seriously and it pay off to be able to understand the requirements and implement them.
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