7. It’s just like the human body!
ERP
MES
PLM
Business Intelligence
CRM
Business Intelligence
PLM
CRM
MESERP
8. Management
Portfolio Management
Resource Management
Project Management
Management Review
Quality Audits
Personnel Training
Research
Market Analysis
Research Notes
Experiment Management
Scientific Test Methods
Technical Reports
Knowledge Library
Development
Design Planning
Requirements
Specifications
Verification and Validation
Design Transfer
Regulatory Management
Production
Device History Record
Supplier Quality
Production Management
Labeling and Packaging
Process Validation
Product Catalog
Quality
CAPA
Non Conformances
Complaints and eMDR
Service
Recall and Field Actions
Trending and Analysis
CAD Integration Bill of Materials Routers Device Master Record ERP Integration
Product Documents Quality Documents Change Control Design History File (Docs)
Risk Management
Intelligent Design History File
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
Level 2 - Controlled Document Management
Level 3 - Intelligent Engineering
Level 4 - Advanced Product Lifecycle Management
Level 1 - Product Lifecycle Management Platform
PLM Maturity Model - 2013 Edition
9. Management
Portfolio Management
Resource Management
Project Management
Management Review
Quality Audits
Personnel Training
Research
Market Analysis
Research Notes
Experiment Management
Scientific Test Methods
Technical Reports
Knowledge Library
Development
Design Planning
Requirements
Specifications
Verification and Validation
Design Transfer
Regulatory Management
Production
Device History Record
Supplier Quality
Production Management
Labeling and Packaging
Process Validation
Product Catalog
Quality
CAPA
Non Conformances
Complaints and eMDR
Service
Recall and Field Actions
Trending and Analysis
CAD Integration Bill of Materials Routers Device Master Record ERP Integration
Product Documents Quality Documents Change Control Design History File (Docs)
Risk Management
Intelligent Design History File
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
Level 2 - Controlled Document Management
Level 3 - Intelligent Engineering
Level 4 - Advanced Product Lifecycle Management
Level 1 - Product Lifecycle Management Platform
PLM Maturity Model - 2013 Edition
CAPA
Management Review
Device Master Record
Complaints and eMDR
Quality Documents
11. Management
Portfolio Management
Resource Management
Project Management
Management Review
Quality Audits
Personnel Training
Research
Market Analysis
Research Notes
Experiment Management
Scientific Test Methods
Technical Reports
Knowledge Library
Development
Design Planning
Requirements
Specifications
Verification and Validation
Design Transfer
Regulatory Management
Production
Device History Record
Supplier Quality
Production Management
Labeling and Packaging
Process Validation
Product Catalog
Quality
CAPA
Non Conformances
Complaints and eMDR
Service
Recall and Field Actions
Trending and Analysis
CAD Integration Bill of Materials Routers Device Master Record ERP Integration
Product Documents Quality Documents Change Control Design History File (Docs)
Risk Management
Intelligent Design History File
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
Level 2 - Controlled Document Management
Level 3 - Intelligent Engineering
Level 4 - Advanced Product Lifecycle Management
Level 1 - Product Lifecycle Management Platform
PLM Maturity Model - 2013 Edition
Device Master RecordBill of Materials
Product Documents Change Control
ERP Integration
Management Review Verification and Validation
Design History File (Docs)
Project Management
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
99% improvement in time to generate
Routers
Supplier Quality
Quality Documents
Process Validation
Design Planning
Requirements
Specifications
Regulatory Documents
56% improvement in on-time periodic reviews
– ease of reporting
48% reduction in volume of COs
75% reduction in CO creation time
41% reduction in time to process a change
75% reduction in validation documents
processing time
12. Mature PLM Scenario
Verification and Validation
Supplier Quality
CAPA
Complaints Management
Bill of Materials
ERP Integration
Change Control
Risk Management
13. Mature PLM Scenario
Verification and Validation
Supplier Quality
CAPA
Complaints Management
Bill of Materials
ERP Integration
Change Control
Risk Management
Customer Calls with a Complaint
Product is failing unexpectedly
The PLM’s analytics tool
automatically identifies a trend
14. Mature PLM Scenario
Verification and Validation
Supplier Quality
CAPA Complaints Management
Bill of Materials
ERP Integration
Change Control
Risk Management
The system sends an alert to a quality analyst on her mobile device
She opens a CAPA - (CAPA is a quality process used to overcome or
prevent serious problems)
15. Mature PLM Scenario
Verification and Validation
Complaints Management
Bill of Materials
ERP Integration
Change Control
Risk Management
A root cause investigation implicates supplier inconsistencies
A critical parameter had been assumed to be consistent between
suppliers
The PLM tool easily illustrates this gap due to advanced traceability
The system helps the user link together the relevant information
The system also helps identify which suppliers are qualified
CAPA
Supplier Quality
16. Mature PLM Scenario
Verification and Validation Supplier Quality
Complaints Management
Bill of Materials
ERP Integration
Change Control
The PLM tool reveals the complaint code indicates a new type of
failure mode that was missed in the original risk analysis
The CAPA is used as a central hub to manage the information
CAPA
Risk Management
17. Mature PLM Scenario
Verification and Validation Supplier Quality
Complaints Management
ERP Integration
Change Control
The control plan NOW includes reviewing critical parameters of
the part during incoming inspection
CAPA
Risk Management
Bill of Materials
18. Mature PLM Scenario
Verification and Validation
ERP Integration
A change is invoked and evaluated to update incoming
inspection procedures
The change impact tool in PLM looks across affected data to
determine the risk of change and appropriate actions
Supplier Quality
Complaints Management
CAPA
Bill of Materials
Risk Management
Change Control
19. Mature PLM Scenario
The change is tested and validated and pushed to production
Supplier Quality
Complaints Management
CAPA
Bill of Materials
Risk Management
Change Control
Verification and Validation
ERP Integration
22. Integware Enterprise “System of Record” Recommendation
(R=System of Record, A=System of Access)Medical Device Process FDA QSR ISO 13485: 2003 PLM ERP MES CRM BI
Quality Manual All All (4.2.2) R
Document Control 820.25(b), 820.40 4.2.3 R A
Control of Records 820.180, 820.186 4.2.4
R
(Part)
R
(Part)
Management Review & Responsibility 820.5, 820.20, 820.25(b), 820.250
4.1, 5.1, 5.2, 5.3, 5.4.1,
5.4.2, 5.5, 5.6, 6.1, 6.3, 6.4,
8.1, 8.4
R
Training 820.25 6.2 R A
Preventive Maintenance 820.70(g) 6.3 R
Contract Review 820.25(b) 7.2 R
Design Control, Risk Management 820.25(b) & (b)(2), 820.30, 820.72 (use)
7.1, 7.2.1, 7.3 (See also
ISO 14971:2007)
R A
Purchasing & Supplier Control 820.25(b), 820.50 7.4
R
(Part)/
A
(Part)
R
(Part)/
A
(Part)
A
Receiving
820.25(b), 820.60, 820.65, 820.70, 820.72
(use), 820.75, 820.80, 820.86, 820.90,
820.120, 820.140, 820.150, 820.180(b),
820.250
6.4, 7.1, 7.4.3, 7.5.1.1,
7.5.1.3, 7.5.3, 7.5.4, 7.5.5,
8.2.3, 8.2.4, 8.3
R
Receiving Inspection
820.25(b), 820.60, 820.65, 820.70, 820.72
(use), 820.75, 820.80, 820.86, 820.90,
820.120, 820.140, 820.150, 820.180(b),
820.250
6.4, 7.1, 7.4.3, 7.5.1.1,
7.5.1.3, 7.5.3, 7.5.4, 7.5.5,
8.2.3, 8.2.4, 8.3
R
Manufacturing, Kitting, Product Release, Production
Control, Process Control, Quality Planning, DHRs
820.25(b), 820.60, 820.65, 820.70, 802.72
(use), 820.75, 820.80(c), (d), (e), 820.86,
820.90, 820.120, 820.130, 820.140,
820.150, 820.180(b), 820.184, 820.250
5.4.2, 6.4, 7.1, 7.5.1.1,
7.5.3, 7.5.4, 7.5.5, 8.2.3,
8.2.4, 8.3
A R
Labeling (product, material, marketing literature)
820.40, 820.120 7.5.1.1 g R A
Shipping 820.130, 820.140, 820.150, 820.160 7.5.5 R
Calibration 820.72, 820.25(b), 820.180(b) 7.6 R ?
Complaints, MDR
Corrections & Removals
Heath Hazard Evaluation
803/804, 820.25(b), 820.100, 820.180(b),
820.198, 820.250
8.2.1, 8.5.1
R
(Part)
A A
R
(Part)
A
Device Master Record 820.181 8.2.1 R A A
Internal Auditing 820.22, 820.25(b), 820.180(b) 8.2.2 R A
Nonconforming Product 820.60, 820.86, 820.90 8.3 R A ? A
Corrective and Preventive Action 820.100, 820.250 8.4, 8.5 R A
23. Management
Portfolio Management
Resource Management
Project Management
Management Review
Quality Audits
Personnel Training
Research
Market Analysis
Research Notes
Experiment Management
Scientific Test Methods
Technical Reports
Knowledge Library
Development
Design Planning
Requirements
Specifications
Verification and Validation
Design Transfer
Regulatory Management
Production
Device History Record
Supplier Quality
Production Management
Labeling and Packaging
Process Validation
Product Catalog
Quality
CAPA
Non Conformances
Complaints and eMDR
Service
Recall and Field Actions
Trending and Analysis
CAD Integration Bill of Materials Routers Device Master Record ERP Integration
Product Documents Quality Documents Change Control Design History File (Docs)
Risk Management
Intelligent Design History File
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
Level 2 - Controlled Document Management
Level 3 - Intelligent Engineering
Level 4 - Advanced Product Lifecycle Management
Level 1 - Product Lifecycle Management Platform
PLM Maturity Model - 2013 Edition
24. Management
Portfolio Management
Resource Management
Project Management
Management Review
Quality Audits
Personnel Training
Research
Market Analysis
Research Notes
Experiment Management
Scientific Test Methods
Technical Reports
Knowledge Library
Development
Design Planning
Requirements
Specifications
Verification and Validation
Design Transfer
Regulatory Management
Production
Device History Record
Supplier Quality
Production Management
Labeling and Packaging
Process Validation
Product Catalog
Quality
CAPA
Non Conformances
Complaints and eMDR
Service
Recall and Field Actions
Trending and Analysis
CAD Integration Bill of Materials Routers Device Master Record ERP Integration
Product Documents Quality Documents Change Control Design History File (Docs)
Risk Management
Intelligent Design History File
Repository Information Model Process Model Process Integration Security Search Collaboration Reporting
Level 2 - Controlled Document Management
Level 3 - Intelligent Engineering
Level 4 - Advanced Product Lifecycle Management
Level 1 - Product Lifecycle Management Platform
PLM Maturity Model - 2013 Edition
25. Potential for Aras
These are things that are getting us excited
Open platform
Advanced reporting
Better fundamental building blocks
Services
Product
Full business process flows
