This webinar is focused on the current state of UDI regulations, the best approaches to medical device UDI Compliance in the cloud and how to gain business benefits by implementing KPIT's UDI Cloud Solution. This is a must-watch session for medical device companies who are preparing for UDI compliance or the ones who have already implemented however looking for a long-term solution.

1. www.kpit.com
www.usdm.com
Medical Device UDI
Cloud Solution

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Introductions
Jay Crowley
Vice President of UDI
Services and Solutions at
USDM Life Sciences
John Danese
VP and Senior Director of
Life Sciences Strategy at
KPIT
Deepak Gupta
Global Practice Director &
Chief Architect, Oracle MDM
Practice at KPIT
Jim MacDonnell
Vice President at USDM Life
Sciences

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Agenda
Current state of Unique Device Identification in the
Medical Device industry
The KPIT UDI Cloud Solution
Validating SaaS
Discussion

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UDI Current State
FDA’s 2013 UDI Final Rule

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US FDA’s UDI System Regulation
2013 Final rule (from 2007 FDAAA 2012 FDASIA)
• Requires nearly all medical devices (as defined in the US) to be
UDI compliant.
• Requires use of UDI in manufacturer’s other regulatory systems
– e.g., recalls, complaints, adverse event reporting.
• Multiple steps and phased Implementation
First Step – Labels and Device Packages:
• Assign Device Identifiers (DIs) to all devices (labels) and their
higher levels of packaging – based on chosen Issuing Agency
(GS1, HIBCC, ICCBBA)
• Standardize date format(s)
• Apply UDI (DI + applicable Production Identifier(s)) to label and
packages – in both AIDC and HRI (plain text)

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US FDA’s UDI System Regulation
The Medical Device Label:
Device Identifier (Device XYZ123)
Production Identifier (Lot #ABC)
Expiration date (YYYY-MM-DD)
Manufacturer
(Labeler)
Web based tool (name/PW)
HL7 SPL (direct, ERP, PLM)
3rd Parties (GDSN, Reed)
Business
Rules
FDA’s
GUDID
For each Device Identifier
Commercial
Distribution
FDA Managed
Public User
Interface
Second Step – GUDID Data
1. Identify, collect, transform, normalize, and
verify source data
2. Store in extensible solution
3. Submit manually or use of an electronic
tool through ESG
4. Manage as updates (e.g., new 510ks) and
changes (new GMDN PT) are made to the
device

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US FDA’s UDI System Regulation
Third Step – Direct Marking
Any device that is subject to the UDI label requirement –
must ALSO have a “permanent marking” providing the
UDI if:
• The device is intended to be used more than once
• Intended to be reprocessed before each use
Example Technology Solutions:
• Direct Part Marking
• “Permanent” label
• Tags
• RFID
• Exception built-in to rule; noted in
design history file
• Has implications for GUDID
Any device that is subject to the UDI label
requirement – must ALSO have a “permanent
marking” providing the UDI

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US FDA’s UDI System Regulation
Fourth Step – Implement Quality System and
Conforming Amendments
• Develop new SOPs/WIs
• Use of barcode verification
• Updates and changes to current processes and
systems
• Any necessary validation activities
• Training
• Use of UDI in these systems and processes
• Part 803: Medical Device Reporting
• Part 806: Corrections And Removals
• Part 810: Medical Device Recall
• Part 814: Premarket Approvals
• Part 820: Quality System Regulation
• Part 821: Medical Device Tracking
• Part 822: Postmarket Surveillance

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US FDA’s UDI System Regulation
Fourth Step – Implementation
• September 24 of:
• 2014: label/package and GUDID for class III and PHS Act licensed devices
• 2015: label/package, GUDID and DM for class II/I implants and life-
supporting/sustaining devices
• 2016: label/package and GUDID for the rest of class II devices
• 2016: Non-sterile implants – UDI at the point of implantation
• 2016: DM for class III devices
• 2018: label/package and GUDID for class I devices
• 2018: DM for class II devices
• 2020: DM for class I devices

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KPIT UDI Cloud Solution

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Digital Transformation is driving the need for higher quality data on the
3rd Platform
The 3rd Platform is the new core of IT market
growth
• Distributing data across cloud silos and devices
• Social media distribution of positive and negative
sentiment
• The network perimeter has disappeared
By the end of 2017, two-thirds of Global 2000
enterprises will have a digital transformation at
the core of their strategy
• Innovation accelerators will rely on high quality data for
success
Data is at the core of digital
transformation. Data without
integrity won’t be able to support
digital transformation initiatives.
IDC Perspective

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Web
site
EBS Salesforce
Future
App
Main
Frame
O
T T
T
Up to 70% of PRODUCT
data is buried in
documents and reports
in various functional
silos, if it exists in
electronic format, at all.
SAP JDE
RepairsSpreadsheet
Legacy
To this….
P R O D U C T
Single Source of Truth for Product Data
Escape from this….
Data Availability and Quality are Big Challenges for UDI Programs

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Scattered and Inconsistent Product Data
Not Just a Data Problem…A Business Process Problem
ERP
Transformation
Migration
Upgrades
Government
Compliance
and Risk
Management
Omni Channel
Commerce
Product
Distribution
Timely
Response to
Customer
Queries
Planning
and
Forecasting
Reports
Customer
Satisfaction
and
Retention
New Product
Launches

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Why Adopt an MDM Approach vs. Outsourcing
Single System of Truth for UDI-Related Data
Improved Data Quality and Governance
Revenue Generation & Customer Retention
Global Compliance Ready
 Single system of
truth for
managing UDI
attributes
 Clearly defined
accountability of
respective
departments on
entering required
UDI information
 Governance to
ensure UDI Data
completeness
 Maintain
compliance with
mergers &
acquisitions
 Leverage
enterprise data
quality solutions
 Automated data
classification &
mapping
 Maintain multiple
DI x-refs: Catalog,
DI, GTIN, HIBCC,
etc.
 Auditability to
track UDI attribute
changes
 Automate UDI
data enrichment
rules across the
enterprise
 Single-source for
e-commerce to
improve up-sell
and cross-sell
opportunity
visibility
 Enable
differentiated
product service
offerings
 Maximize first-
time right product
deliveries
 Accelerate new
product
introductions
 Scalable to handle
future changes for
UDI attribution
and validation
 Flexible to
incorporate
multiple future
global data
requirements
 Store multiple
format (language)
UDI attributes
 21 CFR Part 11
compliant
IT Agility
 Accelerate new IT
projects
 Quickly
understand
change
implications on
BOMs
 Audit Logs for UDI
Compliance

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Extract
Cleanse Consolidate Categorize CommunicateProduct Data
Integration
Services
Any Product
Data Sources
Legacy
Integration
Services
Product Master
Data Cloud
KPIT UDI Cloud Solution
Cleanse &
Synchronize
 Single Source of Truth
 Zero Technology
Overhead
 Built for Purpose
 Open and Extensible
Labeling
Data Pools
Regulatory
E-Commerce

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Extract
KPITiLink
Any Product
Data Sources
Legacy
KPITiLink
Oracle
Product Data Hub Cloud
KPIT UDI Cloud Solution
KPIT P-DaaS
 Single Source of Truth
 Zero Technology
Overhead
 Built for Purpose
 Open and Extensible
Cleanse Consolidate Categorize CommunicateProduct Data
Labeling
Data Pools
Regulatory
E-Commerce

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Path to Cloud – Deployment Recommendations
Consolidation Style
Item Creation/ Maintenance to continue in Sources
Product Hub Cloud for Consolidation and Enrichment
Centralized Style
Item Creation/ Maintenance in Product Hub
ERP is one of the consumers of Clean data
Phase 1
Phase 2

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KPIT UDI Solution - Rapid Implementation Model
Project Planning
Discovery and Design
Demo Based
Requirement Gathering
Fusion Cloud Environment- Access
Build and CRP
Import Metadata/ Item Data
Using KPIT Accelerators
Setup- Apply UDI Pre-Built Template
Configure NIR, Workflows, Rules
Configure Imports and Publish
Data Cleansing and Conversion
iLink Integrate to ERPs/FDA
Testing and CRP
Fine Tuning Setup
Go-Live
UAT
Production Deployment
Go- Live
Gather Product Data
Gather Product Metadata
Gather UDI enrichment Workflows

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This is the Right Strategic Solution IF You…
• Are a Class I device manufacturer that needs to get UDI compliant
• Are a Class III or Class II device manufacturer that has a tactical
solution in place, but now are looking for a long-term solution that
delivers ROI
• Are looking for a platform approach to support needs beyond FDA
UDI compliance – e.g. UK NHS Procurement GS1 compliance and
GDSN data sync mandate
• Are limited in your ability to drive customer engagement initiatives
by device master data scattered across multiple ERP, PLM, CRM and
other systems

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USDM Cloud Services
for KPIT & Oracle
Validating in the Cloud

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1. 21 CFR Part 11?
Compliance?
Validation?
These are critical to each of us.
2. Is Life Sciences ready for Cloud Apps supporting regulated functions – YES
It is no longer if; it is when!
3. How are these addressed on a Cloud project – specifically by Oracle, KPIT and USDM.
4. How KPIT's UDI Cloud Solution meets FDA compliance regulations and is “validation ready”
5. Most importantly how does KPIT and USDM mitigate the risks with prescribed rollouts of new
functionality in a multi-tenant environment.
Cloud Validation

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The USDM Life Sciences Cloud Practice helps life sciences
companies assess, implement, develop, and support compliant
cloud computing solutions.
• Cloud Application Implementation and Development
• Mobile
• Integration • Cloud Strategy for Life Sciences
• Data Migration
• Security and Data Integrity Solutions
• Training and User Adoption
• Communities and Self Service • Field Service
• UDI
USDM Cloud Development Practice

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USDM Cloud Development Practice
• When it comes to an application that affects patient health and safety, companies must have
that application’s infrastructure, features, and processes rigorously tested and documented as
mandated by the FDA. We must have “documented evidence that the system does what the
users need, and will continue to do so.”
• 21CFR (Code of Federal Regulations) Part 11(electronic records and eSig), Part 803 (reporting),
and Part 820 (quality systems)
• When it comes to Oracle and the KPIT Cloud Solution releases, new features in areas such as
security and reporting must be tested and documented.
• Oracle, KPIT and USDM facilitate validation to the extent accepted within Industry Best Practice
– “only the end user (client company) can validate an application.” KPIT and USDM Life
Sciences supports clients to this end.

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Cloud
UDI

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Why the VAP is business critical?
•Reduces validation costs by 50% or more
•Accelerates validation execution
•Specific to Oracle
•Pre-load test scripts (IQ/OP/PQ)
•Maintain validation in the Cloud
The USDM Oracle VAP includes:
Vendor Audit
Part 11
Assessment
Validation Plan
Administration
and
Maintenance
SOP
High Level Risk
Assessment
System
Requirements
Specification
IQ/OQ/PQ
Protocol and
Test Scripts
Traceability
Matrix
Final Validation
Report
USDM VAP (qualification package – updated
validation and verification protocols per release)
USDM Validation Accelerator Packs
 Application specific, standardized approach
 Fully Integrates with the SDLC
 Provides sensible framework for ongoing validation
 Assure acceptable levels of compliance (based on
GAMP5)
 Minimize the cost of total compliance ownership
USDM Validation Accelerator Packs

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USDM Cloud Validation
• Phase 1 – Plan
• Phase 2 – Requirements
– USDM Validation resource begins
validation plan and SRS
• Phase 3 – Design
– Design Specification
– Validation analyst creates framework for
config spec/IQ protocol
• Phase 4 – Build
– Complete config spec
– Creating OQ protocol
• Phase 5 – Test
– Move from dev to QA
– IQ execution and approval
– OQ execution and approval
– PQ execution and approval
• Phase 6 – Deploy
– Move of QA to Production
– Production IQ execution and
approval
– Summary Report to release system
• Phase 7 – Maintain and Support
USDM Life Sciences validation process is integrated in KPIT’s Onboarding,
Configuration and Turn-over to Production Methodology

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• GAMP® 5 recommended practice - preparing and leveraging supplier’s activities to enhance
your own quality practices and project methodologies.
• As can be seen below, are key concepts of the guidance.
USDM Cloud Validation: Helping the App Vendor

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Compliant Cloud Systems…
There are 3 stages in the selection, establishment and maintenance of compliant Cloud
Systems…
Number 1 – Supplier Responsibility for Infrastructure – Selecting the right supplier is key
o Establish a robust, meaningful SLA – people, process, technology
o Perform annual Vendor Audits - Infrastructure qualification, system administration, backup
and recovery processes, system redundancies, security policies, encryption policies,
communications processes

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Number 2 – Functional Qualification and Validation
o Perform Risk Based Validation…
o Continue to leverage your Supplier Activity - Leverage the established supplier processes to
eliminate the need to re-do any qualification on “Low Risk” items
o Validate remaining requirements - according to inherent risk following an approved Risk
Management and Testing Strategy.
Compliant Cloud Systems…

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Compliant Cloud Systems…
Number 3 – Maintaining the Compliant State
o Maintaining a compliant state – in a constant state of flux
o Cloud Vendors/Third Party Providers/Internal analysis of releases
o Analyze each set of release notes – functional updates, service packs, bug fixes
o Determine the risk relevance (GxP function, risk, items effected/potentially effected)
o Mitigate risk – new testing/regression testing

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USDM’s Validation Accelerator
Pack – Verifies Core
Configuration and Scheduled
Release Notes
ValidationPlanforCoreSystem
(baselineconfiguration)
Core System
Requirements
Verification
activities (IQ/OQ)
Verifies
Core System Validation Summary
Report
Administration and Maintenance SOP’s
Core System Change Control
Oracle KPIT Solution “Core” Platform
Release NotesCore System Baseline ConfigurationOracle Deliverable – Part
of Customer Validation
Package
USDM Cloud Compliance Practice
– Platform/Core

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ValidationPlan-CustomerSpecific
ConfigurationandCustomization
Customer
Functional
Requirements
Verification activities
(IQ/OQ/PQ)
Verifies
Customer Validation Summary
Report
Administration and Maintenance SOP’s
Customer Configuration Management and Change Control
Customer Specific System Elements
System/Functionality
Released
Customer Specific
Configuration/Customization
Functional
Risk
Assessment
Customer Deliverable –
part of Customer Validation
Package
USDM Cloud Compliance Practice –
Customer Specific

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Why USDM and KPIT?
Strong Life Sciences domain expertise
Experience with a Life Sciences company’s current systems, processes, and challenges
A integrated “validation” approach to Oracle and the KPIT Cloud Solutions
Existing Oracle and UDI Validation Accelerator Packs (VAPs)

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Questions

35. Technologies for a better world
Thank you

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User Requirements Specification
Functional Design Specification
Technical Design Specification
Configuration Settings
Audit Plan
Performance Qualification ( PQ)
Operational Qualification (OQ)
Installation Qualification (IQ)
Maintenance Qualification
Traceability Matrix
Validation Deliverables:
• Project Plan
• Quality Plan
• Documentation Lifecycle
• Configuration Management
• Change Control
• Incident Management / Disaster Recovery
• SOPs and Training Records
• Operation Support Plans and Procedures
• Testing Strategy, Plans, Results
• Audit Plans and Results
Initiation to Build Transition to ProductionThe “V” Diagram
Deliverables typically provided by customer/user
Deliverables a SaaS provider may provide
Deliverables SI, Validation Partner may provide
Components for Pharma, Biotech, Medical Device Computer Validation
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