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aras.com Copyright © 2012 Aras. All Rights Reserved. Partner Solution Show Case EHT & MedDev Solution Templates Leon Lauritsen Partner (Henley Executive MBA) Minerva ACE Germany

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aras.com Copyright © 2012 Aras. All Rights Reserved.

Partner Solution Show Case EHT & MedDev Solution Templates

Leon Lauritsen Partner (Henley Executive MBA)

Minerva

ACE

Germany

Electronic & High Tech Solution (Focus) Medical Device Solution (Short introduction)

Minerva Group

Product Data Management

SYM_CAP01

Logical_01

Physical_01

Fab_01

600_1

900

700

800

600_2

11-1111-01

11-222-01

11-333-01

Specifications

Bills of Material

Components

Mechanical Designs Test Data

Electronic Schematics

Marketing Literature

PCB Layouts

Documentation

Software

Suppliers’

Suppliers

Suppliers

Design

Partners

Mfg Partners

Service

Partners Procurement

Quality

Service

Engineering

Manufacturing Marketing

Customers

Government

and

Standards

Virtual Value Chain Evolution Drives Complexity

EH&T Solution Overview

CAD

Network Drives

• Enchanced Parts Management • Extended Lifecycle Management • Minor Revision • Advanced Best Practice Change Management • Intelligent Workflow choice based on business logic

• Easy Grant Access • Defined collaboration

processes • Participate in ECO • Create ECR

• Easy extract of information

• Faster than CAD integration • Import to ECO with differences • Maintain history • No manual error

Minerva in Action

Challenge:

• Efficiency, traceability, control and visibility into product

documentation and associated processes

• Multiple data islands combined with manual processes for

handling product documentation, collaboration, change

management, release management and more.

Solution:

• PLM Solution setup specific for Electronics and high-Tech with Mechanics, electronics, and software.

• Change Management

• Collaboration with external partners

Company:

CPAC AB

• HQ S.

Products:

Control Systems

Industry:

Electronics & High-tech

Implementation:

15 Days

Business Profile Business Case

7

Extended into Medical Device industry solution

Quality System Regulation

Quality System

Design ControlsDesign Controls

MaterialMaterial

ControlsControlsRecords,Records,

Documents, &Documents, &

Change ControlsChange Controls

Equipment & Equipment &

Facility ControlsFacility Controls

Production & Production &

Process ControlsProcess Controls

Corrective &Corrective &

PreventivePreventive

ActionsActions

ManagementManagement

i.e. FDA CFR 820

Regulatory Audit

SOPs DMR DHF

-Documents Process history/evidence

Quality Audits . . . Personnel Skills

Product Record

CAPA Process -Problem Reports -Quality Service Request (root cause analysis) -Change Orders

DHF -Phase Gate & -Design Review

-Approved Maufacturers/ -Vendors -NCMR

Records, Documents & Change Control

Design Controls

Material Controls

Corrective & Preventive Actions

Minerva Products

• Industry solution for EHT & Med Dev

• Tools – Minerva Import

– Minerva Special Permission Manager

– PDX Export

– Office Connector

– ConfInnovator

• See more at www.minerva-plm.com

• Come talk to me in the break

aras.com Copyright © 2012 Aras. All Rights Reserved.

Leon Lauritsen Partner (Henley Executive MBA)

Minerva

ACE

Germany

Questions?

for “offline”-Questions contact: Minerva Danmark A/S | Roskildevej 522 DK-2605 Brøndby | www: http://www.minerva-plm.com/ +45 51 59 90 63 (Mobile) Skype: callto://minerva.lla E-mail: [email protected]