2911 enabling document compliance with sap easy document management for a medical device company

8/10/2019 2911 Enabling Document Compliance With SAP Easy Document Management for a Medical Device Company

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Orange County Convention Center

Orlando, Florida | May 15-18, 2011

Enabling Document Compliance withSAP DMS for a Medical

Device Company

Sharon Kaiser, Abiomed

Alan Mendel, LeverX



Real Experience. Real Advantage.

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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 overcamethem




[ 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

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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




[ Who is Abiomed

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!

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 patentspending from over $200m in

R&D

! Over 12,000 patients supported

in over 40 countries worldwide

1987 First heart recovery patient

1981 Abiomed Founded

1992 First FDA approved VAD

2001 First AbioCor® Artificial Heart patient

2009 AB Portable™ driver FDA approved

and first patient discharge

2009 Impella 5.0 available in U.S. for broad

clinical use

2008 Impella 2.5 FDA cleared in U.S. for

broad clinical use

2005 Impella Available in Europe

2010 Impella® 2.5 >1700 patients and in over

350 hospitals in the U.S.




[ 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

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[ 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)

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[ Agenda

!



!


! DMS

!

Automated Workflow

! CAD Integration

!



!

Questions

8




[ 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

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[ 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 theinability 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

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[ 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 re-

filed! 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

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[ 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

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[ 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

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[ 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

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[ 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

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[ 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.

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[ Agenda

!



!


! DMS

!

Automated Workflow

! CAD Integration

!



!

Questions

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[ 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

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[ 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, andother supporting documents

associated to an engineering

change

! Classification to aid searching

!

Various automations put inplace for simplification

! MS Office integration used to

populate forms

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[ 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

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[ ProE CAD Integration

!

Utilize SAP solution for integrating Pro/E directly to SAP,

bypassing CAD specific team data manager (e.g. Intralink/

PDMLink)

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[ Agenda

!



!


! DMS

!

Automated Workflow

! CAD Integration

!



!

Questions

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[ Agenda

!



!


! DMS

!

Automated Workflow

! CAD Integration

!



!

Questions

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[ 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 rollouts 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

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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




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Your Turn!

How to contact us:Sharon Kaiser [email protected] Alan Mendel [email protected]




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]! Thank you for participating.

SESSION CODE:

2911

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