Enabling Document Compliance with SAP DMS for a Medical Device Company

Orange County Convention Center Orlando, Florida May 15-18, 2011 Enabling Document Compliance with SAP DMS for a Medical Device Company ] Sharon Kaiser, Abiomed Alan Mendel, LeverX

[ Learning Points Learn how Abiomed gained control over global engineering documents Learn how Abiomed gained efficiencies through standard routings and workflows for engineering change management Learn what challenges Abiomed faced and how they overcame them 2

[ Agenda About Abiomed & LeverX Abiomed Situation and Challenges Three Aspects of the Project DMS Automated Workflow CAD Integration Solution Demonstration Key Learnings and Best Practices Questions 3

[ About Abiomed Abiomed (NASDAQ: ABMD) is a global technology leader focused on RECOVERING HEARTS AND SAVING LIVES The company develops, manufactures and markets advanced medical technologies designed to assist or replace the pumping function of the failing heart Abiomed Market Overview Global leader for products in acute heart failure market Ships more Ventricle Assist Devices (VADs) than any other company worldwide 4

[ Who is Abiomed Medical Device manufacturer headquartered in Massachusetts with additional mfg facility in Germany Over 350+ employees Experts in Pumping Blood for over 25 years World s smallest heart pumps for cardiologists and surgeons Over 200 patents or patents pending from over $200m in R&D Over 12,000 patients supported in over 40 countries worldwide 2010 Impella 2.5 >1700 patients and in over 350 hospitals in the U.S. 2009 Impella 5.0 available in U.S. for broad clinical use 2009 AB Portable driver FDA approved and first patient discharge 2008 Impella 2.5 FDA cleared in U.S. for broad clinical use 2005 Impella Available in Europe 2001 First AbioCor Artificial Heart patient 1992 First FDA approved VAD 1987 First heart recovery patient 1981 Abiomed Founded 5

[ About LeverX LeverX, a SAP Services Partner, implements SAP PLM, PPM, SCM and related SAP Solutions LeverX Consulting Services: Business, process and strategic consulting Solution architecture services Implementation planning and execution Custom development services Application support services Near/off-shore service Key Industry Partnerships 6

[ SAP Environment One SAP ECC 5.0 instance located at corporate headquarters in Danvers, MA Implemented in mid-2006 in US and late 2007 in Germany SAP Modules implemented: Materials Management Production Planning Sales & Distribution Finance and Controlling HR (Organizational) Quality Management (US Only) Service Management (US Only) Asset Management (Germany Only) 7

[ Abiomed Situation Abiomed was focusing on expanding its global distribution, fueling innovation and new products to broaden the product portfolio Required to meet FDA and ISO9000 standards for document management and system validation and verification Key documents were often stored on different PCs, across multiple geographies, in different venues and in multiple languages, leading to isolated islands of information Were able to manage the process and maintain quality through manual processes and remedial Doc Vault functionality Engineering Change Order review and approval was handled via manual processes 9

[ Challenges Duplication of documents in multiple information islands Inefficiencies in sharing documents Manual version control at times resulted in the use of incorrect information and would require rework to correct Inconsistent ways of organizing the same information and the inability to find documents Unnecessary retention of some documents The loss of documents under review and approval for engineering change orders requiring rework Time delays of getting documents under review back to the approved and controlled status, which could impact vendor notification and production 10

[ Key Objectives of Needed Solution Increase Productivity by saving time Responding quickly to auditor s requests for information Immediately locating documents and highlighting essential information Eliminating lost documents that must be recreated and refiled Cutting time spent copying and distributing documents Speeding document-handling workflow by enabling distribution Improve Accuracy Reducing misfiling Providing more intelligent search methods Streamlining document distribution 11

[ Key Objectives of Needed Solution (Cont.) Increase Communication and Collaboration Share documents over a network and view simultaneously Streamline document-handling procedures Automatically notify appropriate personnel when certain events take place Improve security, including access, audit trails and authentication 12

[ Benefits to be Realized Reduce the time spent on the maintenance of documents Facilitate the collaboration of teams and departments across geographic and organizational boundaries Reduce training and ongoing process education through the use of familiar tools and intuitive navigation Reduce storage costs by fewer documents to store and manage by eliminating duplicate files Reduce costs for administration and archives Reduce costs for paper-based reproduction 13

[ Scope of Effort Implement a solution that would: Manage various types of business documents Support Versioning, Status management, Workflow, Document Distribution Secure data storage / caching Integration / Connection to ERP Master Data sets (as appropriate) Workflow routing for Review / Approval / Status Management Workflow for Engineering Change Control Review / Approval Document Management authorization concept 14

[ Critical Must Have Elements Document Management Compliance (GMP/FDA): Global Centralized Control of Pro/E & all CAD files and models (no files on local PCs) Ability to rapidly circulate and approve ECOs Electronically in all facilities or on the road Assures all ECOs process consistently No Lost hardcopy ECOs Digital signatures across all facilities and functions Ability to view all documents online view portal Annotate/comment on drawings electronically Electronic reminders of review pending Rapid recirculation after approval if a change is made by a second approver Audit logs and electronic signature for approvals capability Integration from our key CAD system, ProE, to SAP 15

[ Additional Requirements Check-in/out of Documents: Prohibits two engineers from modifying the same drawing at the same time Notifies engineer who is making a change to a document Establish Document Linkages Tie documents together electronically Assures if change is made to one document all affected documents are included for review Metrics Audit trails Metrics as a function of: time, product line, location, department, etc. 16

[ Project Implementation Approach Use basic SAP ASAP methodology with time spent early in project to build a prototype and validate the prototype This allowed users to get up to speed on functionality and be firm on their decisions Key item: don t over architect the solution Try to keep it simple and add the right level of automations to help out users where required Keep SAP elements: DMS, Classification, Workflow, ECMs Direct integration of Pro/E to SAP Generation of CAD viewables Digital signatures to support FDA requirements Security to control access and updates 18

[ Key Elements of the Solution Use SAP DMS and workflow as the backbone of the solution Document information record used as the key collecting object for forms, redlines, and other supporting documents associated to an engineering change Classification to aid searching Various automations put in place for simplification MS Office integration used to populate forms 19

[ Workflow Automation Utilize SAPs cross application workflow engine to support notifying the right people at the right time Workflow for Engineering Change Control Review/Approval Utilize workflow organizational structure where appropriate to select correct individuals for work items When not using organizational structure, utilize classification in the document information record to identify other participants 20

[ ProE CAD Integration Utilize SAP solution for integrating Pro/E directly to SAP, bypassing CAD specific team data manager (e.g. Intralink/ PDMLink) 21

[ Key Learnings Project resulted in better and verifiable control over global engineering documents Achieved efficiencies through SAP driven standard routings and workflows for engineering change management Phased implementation model of SAP DMS and continued roll outs to other departments and other types of documents Provide quality training materials and trainers Provide increased Subject Matter Expert support during rollout Convert files in product groupings to better assist originators 24

[ Best Practices SAP DMS can be used to manage and control updates to key documents in your organization The who, why, and when can be tracked Workflow helps automate the process, getting the right information to the right people at the right time You can successfully integrate CAD directly to SAP Be prepared to allow for the right amount of time to train users Be prepared to build some level of automations to make the system acceptable to users Get users trained and involved in using the system early in the process to increase adoption 25

[ Your Turn! How to contact us: Sharon Kaiser skaiser@abiomed.com Alan Mendel alan.mendel@leverx.com 26

[ Thank you for participating. ] Please remember to complete and return your evaluation form following this session. For ongoing education in this area of focus, visit www.asug.com. SESSION CODE: 2911