Implementing a Complaint Management and Reporting System using TrackWise

Implementing a Complaint Management and Reporting System using TrackWise Gambro Use Case Kai Kiefer Manager, IT Center of Excellence ECM & Quality Solutions Gambro Dialysatoren GmbH Yohay Yafe Director, Professional Services Sparta Systems

Agenda Why emdr? (a Business View) What is emdr? (a Technical View) How did we implement emdr at GAMBRO? Who is GAMBRO? Project essentials (when, how, why) Solution overview (building blocks) TrackWise workflow & record design Conversion from TrackWise record to ICSR Submission workflow to FDA (ESG) emdr in the context of Gambro complaint handling and why we choose TrackWise Testing & validation approach Lessons learned during implementation Q&A

Why emdr? (an FDA View) Adverse events and product problems for medical devices are sent to FDA Center of Devices and Radiological Health (CDRH) using MedWatch 3500A. > each MedWatch Report is getting manually transferred into the a central database MAUDE CDRH implemented 2009 the support of an electronic transfer with a 4 year voluntary period After that Paper submissions are still possible but requires a handling cost Motivation for FDA Assumption is today there is a underreporting in medical devices compared to drugs > Push to industry to report more and more frequent Reduce costs and increase transparency

Why emdr? Motivation for Industry Compliance / Traceability Costs Material, Shipping ~10 (standard) Resources prepare Shipment/Archiving 30min ~40 60 Total costs per MedWatch ~ 50 70 > Yearly Volume 500 Submission > 25.000 /Year

What is emdr? (a Technical View) emdr = electronic Medical Device Reporting XML File, describes the data captured in MedWatch Report conform with HL7 ISCR, like Adverse Events used for Pharma Use of FDA electronic Submission Gateway (ESG) which routes XML file to FDA Center of Devices and Radiological Health (CDRH) Data than will be imported into FDA CDRH MAUDE database Additional Features Support single reporting and batch reporting Support initial and follow up reporting Support of attachments Sends acknowledgements 2 Ways for Manufactures to submit manually using FDA esubmitter Automated using a central database

emdr High level Steps Convert into emdr Sent to FDA FDA Gateway FDA CDRH MAUDE DB

emdr Example Two Challenges 1. Generate an XML message compliant to HL7 ICSR 2. Use NCI / MAUDE coding values

Two Solutions Free FDA Tools Enterprise Solution Convert into emdr FDA esubmitter TrackWise emdr Sent to FDA ESG FDA WebTrader AS2 Gateway solutions Axway, SAP PI, /nsoftware

FDA esubmitter http://www.fda.gov/forindustry/fdaesubmitter/

FDA WebTrader

How did we implement emdr at GAMBRO? Gambro is a global medical technology company with products and therapies for Kidney and Liver dialysis, Myeloma Kidney therapy, and other extracorporeal therapies for Chronic and Acute patients. Founded in 1964, Gambro today has 7 600 employees, production facilities in 9 countries and sales in more than 100 countries. Revenues of SEK 12 billion, with majority of business and infrastructure in Europe

Gambro s Portfolio Chronic Care 2. Acute Care 1. Ventures Hemodialyisis Kidney, Liver, Fluid Water, Vascular access, overload, Sepsis New therapies Gambro s incubator business to build a leading membrane technology business for adjacent extracorporeal therapies & life science applications System integration for improved outcome Complete system for demanding situations New therapies

Project Scope Gambro has been using TrackWise since 2006 as a global database for complaint handling, in 2009 the process had been optimized and streamlined ~ 1.000 Complaints & 5.000 Repairs/ month handled > today more 700.000 records Requires coordination of MDRs from 13 different manufacturing sites a cross the world Implement full end to end emdr solution integrated with the current CEM Process MDR Creation in TrackWise MDR Review in TrackWise MDRApproval for submission in TrackWise Creation and validation of technical emdr file Tracking of FDA responses in TrackWise Support of Sending Attachments Sending Updates Out of Scope Submission of ADRs / ADERs (effort will be reviewed after emdr implementation) Submission of ADRs / ADERs (effort will be reviewed after emdr implementation) Submission to other Authorities than FDA

Envisioned Solution TrackWise Complaint Proce ess Reportable Write Review MDR Approve emdr Sent Acknowledged Event Reported SAP XI AS2 Connector /nsoftware emdr Ack(s) FDA GATEWAY

Project Approach for TrackWise Implementation Oct Dec Jan May June 2010 2010 2010 2011 2011 Prepare Change & Documentation Request FDA Access Update and Qualify TrackWise Configuration Setup / Qualify Gateway Suspe ension Peri iod Perform PQ / incl FDA Go Live User Training

GambroTrackWise Records Customer Event Investigation Vigilance Report emdr Report emdr Supplemental Report

emdr Roles / Records Sales Complaint Handler Site Complaint Handler Manager Clinical Investigator Americas er Event Custom Vigilanc ce Report emdr t / Supplem mental VP Global Regulatory Compliance Report

TrackWise Workflow & Record Design QA Manufacturer Automail US Regulatory Office TrackWise Server QA Manufacturer

Section B: Adverse Event or Product Problem

Section D: Suspected Medical Device By selecting the Brand Name related information will be automatically populated.

Auto Creation of Report Numbers Based on Device Manufacturer Manually entered, no solution yet

Print outs

Conversion from TrackWise Record to ICSR Use TrackWise Export Utility Features Runs as a service and connects to the TrackWise Database (like Coordinator) Triggers exports and Imports into records and can be linked into coordinator by posting activities Maps TrackWise fields and values into ICSR XML File Future will provide file handling to EDI/Web Services interfaces >Details: See Application Note from Sparta

Conversion from TrackWise Record to ICSR Use MAUDE Values than it will be mapped automatically

Conversion from TrackWise Record to ICSR Export Utility Posts Activities Coordinator Fetches Posted Activities

Submission Workflow to FDA (ESG) We have chosen to establish a dedicated AS2 Gateway To isolate validation/qualification and change control efforts To reduce costs /nsoftware AS2 Connector (http://www.freeas2.com/) < 1k Requires some configuration i effort (for routing messages correctly) l) TWS Server A2 Gateway Fire ewall AS2 Message AS2 Message FDA ESG (Gateway) AS2 Gateway -WIN2k3 Server - IIS & AS2 Connector - Certificate Gambro Test Gateway

And now the cool thing. all Transactions are imported back into TrackWise and all Transactions are imported back into TrackWise and readable by the user into the AuditTrail

FDA ESG Interesting Notes Obtaining FDA Production Account 1. Register Test Account (letter & certificate) 2. Perform Testing 3. Setup Production and Approval Tests to perform A complete Initial 3500A A complete Initial 3500A with an attachment A complete Initial 3500A followed by a supplemental 3500A (be submitted after initial is loaded successfully) A complete Initial 3500A with section F filled out A complete Initial 3500A and source report(s) Must read documentation FDA ESG Guide & FAQ http://www.fda.gov/forindustry/electronicsubmissionsgateway/ emdr FAQ http://www.fda.gov/forindustry/fdaesubmitter/ucm107914.htm

Why we choose TrackWise emdr in the context of Gambro Complaint Handling

Lessons Learned During Implementation TrackWise Implementation Implement emdr as MedWatch Form Use MAUDE values > lower training and documentation effort (as well as configuration and testing effort ) Use of Auto numbering a is great value, reduces need of manual coordination work User Facility Report Numbers issue unresolved today Use of 510K list makes creation of emdr a wash Consider to make a Crystal MDR report (if you do not have one yet) TrackWise Export Utility Great value in getting a configuration done quickly and safely, reduces test efforts > Wish to have a more pre packaged solution by including the some good prep material Gateway Setup Get people involved familiar with AS2 handling and certificates Caused us a 3 4 weeks delay due to misunderstandings Setup a outside AS2 test facility, costs are low <10k but value If you do not have an validated AS2 gateway today consider building a dedicated one Validation & Testing Qualification/Testing effort like normal TrackWise process using Test Gateway Perform FDA Testing as part of your PQ, consider using your Production Environment (so you test records are maintained)

Q&A CDRH Electronic Medical Device Reporting (emdr) Webinar Announcement Find out all you need to know to take the mystery out of electronic reporting at one of our upcoming free interactive webinars (no registration required) and meet CDRH s emdr Team: Friday, June 03, 2011, 1:30 PM 5:00 PM EDT Friday, August 05, 2011, 1:30 PM 5:00 PM EDT Friday, September 30, 2011, 1:30 PM 5:00 PM EDT Friday, November 18, 2011, 1:30 PM 5:00 PM EDT http://www.fda.gov/medicaldevices/deviceregulationandguidance/postm arketrequirements/reportingadverseevents/emdr / ElectronicMedicalDeviceReporting/ucm252958.htm Or Google

Implementation Approaches Evolution of paper pp 3500A to emdr Modify workflow to support ACKs, data validation errors Retain 3500A report template in case of FDA Gateway downtime Incremental addition of emdr to complainthandling (without electronic 3500A) Add MedWatch elements to complaint/regulatory reporting process Workflow, group permissions to support emdr process New complaint handling solution with emdr Complaint/investigation/assessment/regulatory report processes Security, responsibilities at different levels Streamlined, complete solution B2Bgateway solution

Implementation Approaches Implementation points to consider: Storage of emdr file and ACKs All functional and non functional failure points emdr file does not get generated What to do when gateway is down Look for the root cause/ Alternative gateway. What to do when ACK3 comes back negative Look for the root cause and take decision (Workflow wise) FDA audit what to show? READ, READ, READ! emdr website Keep updated with 3500A updates Notice of regulation

Transition Harmonize complaint and MedWatch processes Set up EDI (Electronic Data Interchange) tool to submit emdr file to FDA Set up EDI tool to process Acknowledgements (3) E Mail notifications, Dashboard set up to alert user based on dtil details of Ak Acknowledgements ld Automatically progress MedWatch if submission is valid, and passed Workflow activity, e mail notifications in case of failure message from FDA

emdr Project Team Roles and Responsibilities Role Responsibilities Project Sponsors Provides overall strategic direction approve scope changes resolve project issues escalated to this level promote project throughout organization support project leaders Business Lead communicate with FDA build consensus with MDR users assist in requirements gathering, user acceptance testing emdr requirements knowledge leader IS Lead manager overall IS solution and delivery escalate issues as needed main conduit to business lead Vendor representative Support internal resources Escalate software issues Provide domain expertise Project Manager Manager project timelines and schedules Escalate IS/Business issues Validate overall testing Complaint/MDR team Provide business requirements for emdr participate in user acceptance testing, generating emdr files evaluate emdr prototypes Vendor software Lead Manage software solution delivery and implementation Support software issues Ensure software complies with FDA requirements B2B Gateway Lead Manage Gateway solution delivery and implementation Support gateway issue resolution Ensure Gateway complies with FDA's Gateway requirements Quality Assurance Advice Project Managers on Quality needs Approve all quality documents

Questions Thank You