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www.kpit.com
www.usdm.com
Medical Device UDI
Cloud Solution
© KPIT Technologies Limited
Introductions
Jay Crowley
Vice President of UDI
Services and Solutions at
USDM Life Sciences
J...
© KPIT Technologies Limited
Agenda
Current state of Unique Device Identification in the
Medical Device industry
The KPIT U...
© KPIT Technologies Limited
UDI Current State
FDA’s 2013 UDI Final Rule
© KPIT Technologies Limited
US FDA’s UDI System Regulation
2013 Final rule (from 2007 FDAAA 2012 FDASIA)
• Requires nearly...
© KPIT Technologies Limited
US FDA’s UDI System Regulation
The Medical Device Label:
Device Identifier (Device XYZ123)
Pro...
© KPIT Technologies Limited
US FDA’s UDI System Regulation
Third Step – Direct Marking
Any device that is subject to the U...
© KPIT Technologies Limited
US FDA’s UDI System Regulation
Fourth Step – Implement Quality System and
Conforming Amendment...
© KPIT Technologies Limited
US FDA’s UDI System Regulation
Fourth Step – Implementation
• September 24 of:
• 2014: label/p...
© KPIT Technologies Limited
KPIT UDI Cloud Solution
© KPIT Technologies Limited
Digital Transformation is driving the need for higher quality data on the
3rd Platform
The 3rd...
© KPIT Technologies Limited
Web
site
EBS Salesforce
Future
App
Main
Frame
O
T T
T
Up to 70% of PRODUCT
data is buried in
d...
© KPIT Technologies Limited
Scattered and Inconsistent Product Data
Not Just a Data Problem…A Business Process Problem
ERP...
© KPIT Technologies Limited
Why Adopt an MDM Approach vs. Outsourcing
Single System of Truth for UDI-Related Data
Improved...
© KPIT Technologies Limited
Extract
Cleanse Consolidate Categorize CommunicateProduct Data
Integration
Services
Any Produc...
© KPIT Technologies Limited
Extract
KPITiLink
Any Product
Data Sources
Legacy
KPITiLink
Oracle
Product Data Hub Cloud
KPIT...
© KPIT Technologies Limited
Path to Cloud – Deployment Recommendations
Consolidation Style
Item Creation/ Maintenance to c...
© KPIT Technologies Limited
KPIT UDI Solution - Rapid Implementation Model
Project Planning
Discovery and Design
Demo Base...
© KPIT Technologies Limited
This is the Right Strategic Solution IF You…
• Are a Class I device manufacturer that needs to...
© KPIT Technologies Limited
USDM Cloud Services
for KPIT & Oracle
Validating in the Cloud
© KPIT Technologies Limited
1. 21 CFR Part 11?
Compliance?
Validation?
These are critical to each of us.
2. Is Life Scienc...
© KPIT Technologies Limited
The USDM Life Sciences Cloud Practice helps life sciences
companies assess, implement, develop...
© KPIT Technologies Limited
USDM Cloud Development Practice
• When it comes to an application that affects patient health ...
© KPIT Technologies Limited
Cloud
UDI
© KPIT Technologies Limited
Why the VAP is business critical?
•Reduces validation costs by 50% or more
•Accelerates valida...
© KPIT Technologies Limited
USDM Cloud Validation
• Phase 1 – Plan
• Phase 2 – Requirements
– USDM Validation resource beg...
© KPIT Technologies Limited
• GAMP® 5 recommended practice - preparing and leveraging supplier’s activities to enhance
you...
© KPIT Technologies Limited
Compliant Cloud Systems…
There are 3 stages in the selection, establishment and maintenance of...
© KPIT Technologies Limited
Number 2 – Functional Qualification and Validation
o Perform Risk Based Validation…
o Continue...
© KPIT Technologies Limited
Compliant Cloud Systems…
Number 3 – Maintaining the Compliant State
o Maintaining a compliant ...
© KPIT Technologies Limited
USDM’s Validation Accelerator
Pack – Verifies Core
Configuration and Scheduled
Release Notes
V...
© KPIT Technologies Limited
ValidationPlan-CustomerSpecific
ConfigurationandCustomization
Customer
Functional
Requirements...
© KPIT Technologies Limited
Why USDM and KPIT?
Strong Life Sciences domain expertise
Experience with a Life Sciences compa...
© KPIT Technologies Limited
Questions
Technologies for a better world
Thank you
© KPIT Technologies Limited
User Requirements Specification
Functional Design Specification
Technical Design Specification...
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Medical Device UDI Compliance in the Cloud

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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.

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Medical Device UDI Compliance in the Cloud

  1. 1. www.kpit.com www.usdm.com Medical Device UDI Cloud Solution
  2. 2. © KPIT Technologies Limited 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
  3. 3. © KPIT Technologies Limited Agenda Current state of Unique Device Identification in the Medical Device industry The KPIT UDI Cloud Solution Validating SaaS Discussion
  4. 4. © KPIT Technologies Limited UDI Current State FDA’s 2013 UDI Final Rule
  5. 5. © KPIT Technologies Limited 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)
  6. 6. © KPIT Technologies Limited 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
  7. 7. © KPIT Technologies Limited 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
  8. 8. © KPIT Technologies Limited 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
  9. 9. © KPIT Technologies Limited 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
  10. 10. © KPIT Technologies Limited KPIT UDI Cloud Solution
  11. 11. © KPIT Technologies Limited 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
  12. 12. © KPIT Technologies Limited 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
  13. 13. © KPIT Technologies Limited 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
  14. 14. © KPIT Technologies Limited 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
  15. 15. © KPIT Technologies Limited 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
  16. 16. © KPIT Technologies Limited 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
  17. 17. © KPIT Technologies Limited 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
  18. 18. © KPIT Technologies Limited 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
  19. 19. © KPIT Technologies Limited 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
  20. 20. © KPIT Technologies Limited USDM Cloud Services for KPIT & Oracle Validating in the Cloud
  21. 21. © KPIT Technologies Limited 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
  22. 22. © KPIT Technologies Limited 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
  23. 23. © KPIT Technologies Limited 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.
  24. 24. © KPIT Technologies Limited Cloud UDI
  25. 25. © KPIT Technologies Limited 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
  26. 26. © KPIT Technologies Limited 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
  27. 27. © KPIT Technologies Limited • 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
  28. 28. © KPIT Technologies Limited 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
  29. 29. © KPIT Technologies Limited 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…
  30. 30. © KPIT Technologies Limited 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
  31. 31. © KPIT Technologies Limited 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
  32. 32. © KPIT Technologies Limited 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
  33. 33. © KPIT Technologies Limited 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)
  34. 34. © KPIT Technologies Limited Questions
  35. 35. Technologies for a better world Thank you
  36. 36. © KPIT Technologies Limited 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 3/20/201733

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