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Connecting the Value Chainfrom Idea to Market
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PLM has provided efficiency and productivity benefits helping manufacturers shorten design cycles,
but now, coupled with advanced digital solutions such as AI and ML, it has the capacity to deliver more innovation and improve the design to manufacturing integration
ERP
Establishing a digital platform can enable the transformation of product design and development, production management, and customer service models
The Digital Value Chain
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Product Service and Work Management
Health & Condition
Design/Engineering/ Manufacturing Documentation(P-BOM, E-BOM, M-BOM)
Engineering
Traditional/ Additive Manufacture
Prototype & Collaboration
Engineering Simulation& FEA
Ideation
Supply Chain Optimization
Analytics & Prediction
Generative Design
Augmented Reality (AR)
Virtual Reality (VR)
3DPrinting
Internet of Things (IoT)
ConceptPDM
PLMProductRecord
MES
Digital Twin
In Market
Productivity
Create MakeDiscover Sell
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The availability of intelligent data and providing it to the right functions at the right time creates new opportunities to reduce risk, improve quality, and accelerate innovation
Market Insights
ProductRequirements
Concept Setup
Item Setup
BoM/Formulation
Release New Product & Equipment Design
Setup New Item for Manufacturing
Equipment Configuration
Innovation Mngmt.
Product Development & Formulation
Product Data Record
Manufacturing / Production Line
IoT AI
Monitor Color Accuracy, Temperature, Humidity
Analyze Accuracy Deviations and Correlate to Environmental Conditions, Shifts, Resources, Suppliers and others.
Project Management: Manage new product and equipment project
Product QualityCapture Audit Results Create CAPA
InMarket
Smart Connected Value Chain
Product Lifecycle Intelligence – Predict cost of change, time to implement change, resource by region etc.
How about…?
Requirements and Digital content management
Virtual/Digital clones and digital verification and validation
Virtual/Digital models
Systems Engineering approach to product development adapted by industry is achieved through the utilization of the digital tools aligned with the process below
Digital product creation and validation
N E E D S S Y S T E M
Requirements
System Architecting
SubsystemDesign
ComponentDesign
ComponentTest
SubsystemIntegration
System Integration
System Validation
Process, Manufacture,
Assembly
M E S MES
Definition &Decomposition
Integration& Verification
Simulation& Verification
User Needs
Design Input
Design Process
Design Output
MedicalDevice
VERIFICATION
VALIDATION
REVIEW
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Digital opportunity is built upon a solid product record foundation
PLM
Product PackagingProcessing
Finished Product
PR
The Connected Product Record
through
Systems and Data
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But there is one common theme that spans across industries: for all digital efforts, data is the underlying raw material. And it’s time to get your data under control.
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We work with our clients to lay the right foundation, set the course and take the first steps.
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We think of Digital as both strategic and practical.
Visit www.kalypso.comto experience Smart Connected Discover to Make in real-life
Medical Device Capability Accelerators
Part / BOM ManagementCAD Data Management and
Model Based Enterprise (MBE)Document Management
Design Control & Design
Review (DHF/DMR)
Change Management Nonconformance Complaints CAPA & SCAR
New Product Introduction (NPI)
Project Management
Regulatory Information
Management (RIM)
Electronic Records
Management (ERM)
Product Lifecycle Intelligence
(PLI) - Machine Learning,
Artificial Intelligence (AI), &
Predictive Analytics
Roles / Groups & Access
ControlElectronic Signatures Automated Testing Validation Documentation
Pre-configured, leading practice business processes using Windchill PLM and QMS for the following capabilities:
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CAD Management for a Model Based Enterprise (MBE)
Leading Practice• Enforce use of a standard set of CAD Management practices (templates, CAD
behavior configuration files, numbering & revision sequences, and approvals)
to ensure support of the expectations of a Digital Model-Based Enterprise.
Capabilities• Supported CAD Tools (Creo 4, Solidworks 2019, later versions and other tool
suites coming soon)
• Example templates (start parts and drawings with linked parameters,
restricted parameter files, application behaviors, etc.)
• Coherent Naming, Numbering, and Parameter mapping to Windchill Attributes
based on Windchill Behavioral Preferences
• Common Numbering & Revision Sequences, Roles and ACLs, Lifecycle
with Maturity-based Data, Approvals Rules, Attribute Assignment,
default Behavioral Preferences shared with Parts and BOMs
• Supports both Bottom-Up (CAD first) and Top-Down (Part first) approaches
• Simplified drawing initiation – naming, numbering, and parameter value rules
• Customized Check-In enforces cascading parameter and attributes rules
• Supports CAD-Driven Product Structure in Part and BOM Management
Value• CAD usage aligned with integrated Master Data and Digital Model-Based
Enterprise vision
• CAD created to be enterprise ready
Data Set Automation
The ASME Y14.41 Data Set Concepts are supported by a series of small CAD-side automations
and Windchill-side configurations. Product definition can start with any Data Set element using
either “Top Down” and “Bottom Up” design approaches.
• Honor the “create data once and propagate it” paradigms.
Part
CAD Drawing (2D Data)
CAD Model (3D Data)
Referenced By
Owner
ContentMetadataMaterials,
Finishes,
ProcessesNotes
Analytical Data,
Test RequirementsAssociated
Lists
Model Drawing
Part
ASME Y14.41 Data Set Concepts supported by light automation
• Data required for complete definition may be
integral to, or referenced by, the product
definition data set
• Data not integral product definition data set, but
describing the product, may be revised
independently
• Related data may be manually set or computer
generated