May 21, 2014
Leveraging UDI Database Requirements to Drive Data Governance
Rene ZoelflBusiness Development Manager Medical Devices
2MEDICAL DEVICES
FDA’s Regulation on Unique Device Identification
21 CFR 830 (UDI
regulation)
Not another FDA submission
process
FDA’s view on a product data
centric enterprise
Founded on the believe that there is only one truth
regarding product data
© 2014 PTC
© 2014 PTCMEDICAL DEVICES
How this journey developed…
4MEDICAL DEVICES © 2014 PTC
“This rule is intended to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States for safe and effective use… The rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use”
Class II, Implantable
(9/2015)
UDI (Unique Device Identification) Regulatory Timeline
PTC UDIsolution
released (9/2013)
Class I, All
(9/2018)
Congress Mandatesthe unique identification of
medical devices
PTC R&D beginswith the FDA and majordevice manufacturers
FDA UDIproposed ruling
Class III devices (9/2014)
Class II, Other
(9/2016)
FDA UDIruling published (9/2013)
2014-18: Enforcement begins for…
FDA UDI Ruling
Worldwide UDIregulations in work
(April 2013, IMDRF)
2005 2007 2009 2011 2012 2013 2014 2015 2016 2018
492,000 adverse event reports / year
283,000 involved an injury
17,700 involved a death
5MEDICAL DEVICES 5© 2014 PTC
Agenda
• A checklist for FDA UDI compliance
• Data management as lever for streamlined submissions– Current Situation– Challenges– Best Practices
• How PTC solutions support UDI and data governance
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Executive Scorecard for a UDI Submission Solution
Requirements, Should-Have’s, & Better to Have’s
Compliance by the deadline
System available to meet compliance deadline
System supports 21 CFR Part 11 compliance*
HL7 SPL (XML) Formatted submission
Communicated to ESG (electronic submissions gateway)
Capture acknowledgements from FDA
Triage accept / reject / delayed status (7 days to correct**)
High-level reportability for compliance across all products
Collect and aggregate regulatory data centrally
Templates / workflows / bulk load and approve
Create, review, and approval permissions
Connect to product development so GUDID data is current / UDI referenced in DHF (per 21 CFR Part 820.184)
Connect to CAPAs/Complaints/NCs/Adverse Event reports (21 CFR Part 820.198)
Architecture to accommodate future global regulations
124 days left to comply with the rule for class III devices
© 2014 PTCMEDICAL DEVICES
Is there a single and reliable source of audit ready product data today?
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Problem Definition: Market and Regulatory Submissions
Our observation: multiple systems house the 65 data points required by FDA
FDA GUDID
DB2
DB1
DB4
DB3
GDSN
Future Global UDI Databases
Global Providers
US Providers
Group Purchasing
Org’s
Product Changes
New Geographies
Internal processes / approvals
.CIN
.SPL
.???
Market / eCommerce Data
Regulatory Submissions
.???.???
9MEDICAL DEVICES
Our Recommended Approach for Streamlined Submissions
© 2014 PTC
SYNCHRONIZE
CENTRALIZE
HARMONIZE
FDA GUDID
DB2
DB1
DB4
DB3
Global Providers
US Providers
Group Purchasing
Org’s
GDSN
Future Global UDI Databases
Workflows/ Approvals
.CIN.SPL
.???
Changes / History
Submissions/ Output
Future Regulations
submissions with unique market / regulatory needs
data as changes are made upstream
AGGREGATE REVIEW / CLEAN GOVERN
© 2014 PTCMEDICAL DEVICES
What are the challenging parts?
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• Transparency about all devices falling under the rule
– How many devices are affected at what deadline?
• Clarity on– Which data are available?– Where are the 65 data points required for FDA UDI
Submission housed within the organization?– Which data are electronically accessible?– Which data are correct for submission?– Are the data available in the required format?– Can the data be stored centrally?
• What do the FDA required attributes mean?– i.e. what is brand name or the catalogue number in the
context of the customer
Where are all the data stored?
Critical questions at the beginning
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• Who within the organization can validate the data?
• Who is responsible for the program?
• Need people in place that are dedicated to UDI
– It isn’t just about submission, it is all about validation and maintenance
– It isn’t solely an IT topic, but a regulatory challenge
• How do I setup the account structure for communication with the FDA.
Who is responsible within the Organization?
Many stakeholders in many organizational units
© 2014 PTCMEDICAL DEVICES
Best practices learned from the field
How could the challenges be addressed?
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An approach to start with: UDI Requirements Assessment
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STAY COMPLIANT AND REDUCE THE RISK OF NEGATIVE
AUDIT FINDINGS
Best Practice IData Governance ensure Accuracy and Uptodateness
Automatically stay compliant as product data
changes upstream, as required by the UDI rule.
• Submissions Stay Current as Products Change– Live synchronization of UDI submissions with
upstream data source(s)– As product data changes in upstream system(s), the
system creates new or updated submissions
• Available UDI Data Management– Centralized storage and management of UDI in a
purpose-built UDI data model– Route to the right organizational roles via
create/edit/review/approval workflows– Template and bulk-load capabilities for creation /
approval of submissions– History and change/configuration
management of UDI data to aid in future compliance with worldwide UDI regulations
– Pre-submission validation using the same FDA algorithms used post-submission
W H Y I T M AT T E R S
W H AT I T M E A N S
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• Ensure data quality, integrity, and security– Capture and manage all required UDI information
from multiple systems into a single data model
• A single, centralized data model for e-commerce and UDI (starting with FDA GUDID) submissions– Scalable to future requirements while preserving data
integrity and ease-of-use– Strong Integrations with other systems to rapidly pull
UDI data into a single source
• Centralize workflows, edits, reviews, and approvals– Pre-configured workflows route UDI information to the
correct roles for review and approval
• Keep business processes and roles aligned with e-commerce and regulatory data management needs
REDUCE TIME AND EFFORT, IMPROVE ACCURACY OVER MANUAL METHODS
Best Practice IICentralize Product and Regulatory Data
Improve Efficiency and Reduce Risk with a single source of truth for product and regulatory
data
W H Y I T M AT T E R S
W H AT I T M E A N S
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HELP ENSURE COMPLIANCETO PROTECT FROM RISK
Best Practice IIIRegulatory Compliance reducing risk and effort
Extend compliance to include related industry requirements – with no
additional effort
• 21 CFR Part 11-Supportive Training– Completely pre-built, documented training developed
and delivered by industry experts via eLearning and instructor-led options
– Gain compliance faster by eliminating the need to create and conduct training internally
• 21 CFR Part 11-Supportive Technology– Audit trail technology, electronic signatures, and
secure review of electronic data– Complete solution validation package facilitates
required validation process– Speed and streamline the audit process; help to
reduce uncertainty and risk during audits
• Accommodate Future UDI Regulations– Robust software architecture anticipates UDI
regulations from future worldwide markets– Prepare to meet future global UDI rules
and future changes to FDA UDI
W H Y I T M AT T E R S
W H AT I T M E A N S
© 2014 PTCMEDICAL DEVICES
How did PTC reflect those best practices?
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DB4DB3DB2DB1
We designed our solution to facilitate data governance
Lower the risk of noncompliance with accuracy, efficiency, traceability and scale
- 21 CFR Part 11-supportive technology
- 21 CFR Part 11-supportive training
- 21 CFR Part 830 – supportive solution
- Solution technology facilitates validation
- Accommodates future global UDI rulings
Regulatory compliance
Centralized Data Management
Data Governance
- Dynamic connections ensure changes flow down
- Available centralized UDI regulatory data management with:
- Bulk-load capabilities
- Collection, control of data from disparate sources
- OOTB workflow to create, review, approve submissions
- Pre-built templates to bulk-create and bulk-approve
- Pre-submission data validation with FDA algorithms
- Change/configuration management of UDI data
- Automatic data transformation
- Human-readable PDF
- Monitor and track FDA responses
- Rejections/exceptions flagged for correction
- High-level graphing and reporting
- Historical record of submissions
UDI data
Centralized data if pre-existing
OR…
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Revision control and data stewardship
5.0
PTC’s Unique Device Identification Solution
► Process Overview
Collection of Data Collection of Data
Review & Approvalse-signature
Review & Approvalse-signature
StartStart
Creation Creation
FDA SubmissionFDA Submission
EndEnd
Ongoing Change & Configuration MgmtOngoing Change & Configuration Mgmt
Regulatory Affairs
2.0
3.0
4.0
1.0
5.0
PLMSystems
ERPSystems
Home Grown
Systems
MDMSystems
Doc & LabelingSystems
Product “Specs”
Collection of Products & key UDI attributes from Disparate systems –
Automatic bulk Creation of UDI Objects & Initiation of Workflows
1.0
© 2014 PTC
UDI Creator applies final editsto refines UDI submission then
submits for approval
2.0
Generate HL7 SPL, submit to FDA Electronic Submissions
Gateway (ESG) – Monitor Acknowledgments
4.0
E-Signature and review/approval workflows
3.0
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Technical Architecture Overview
The PTC UDI Complete Solution Includes Services and Software Components.• PTC Core UDI Submission Engine – Manages Inputs, Workflows, Approvals, Configuration
and Change • PTC Submission Cartridges – Manage formatting, communication & monitoring for Agency
Submission
Doc / Labeling
Regulatory
PLM
ERP/MDM
Spreadsheet Import
UDI Database
Create Wizard
UDI Algorithm
PTC Core UDI Submission Engine
UDI Templates
“Populate from Source Method”
Calls Data Populators if used
Wizard or
Spreadsheet US FDA Cartridge
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Vision: Centralized Data Management
© 2014 PTC
Product Based Information – Design, BOM, Parts, Variants etc..
Document Based Information – SOPs, Policies, Quality Manual
Quality Records Based on Products & Documents – CAPA, NCs, Complaints, Audits etc..
Design Manuf.Distribution
& UseSupport & Service
Concept
• A Documents Backbone - Manage & Control all key documents / Document Control • A Products Backbone - Provide Control of Product information / Design Control, DHF,
DMR, BOM and BOO • A Quality Backbone – Quality Activities & Processes interact with the Anchor Points for Products and Processes
RequirementsDesign Inputs
Risk & Hazards Failure ModesDesign ValidationDesign ReviewsRegulatory submissionsMaterial Compliance
CAPANonconformanceManufacturing Process PlansManufacturing Instructions
CAPAComplaints
CAPAComplaintsService Issues
FDA Market Approval
Enable streamlined data governance over the entire product life cycle
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Summary
Corner Stones for a product data centric UDI implementation
• UDI as regulatory must have or opportunity to drive future data quality and governance
• Communicate and win stakeholders
Develop Strategy and Scope
• Systems and Owners• Gaps to UDI requirements• Inconsistencies
Identify Data Sources
• Data preparation and evaluation• Iterative approach; build, evaluate, define process• Review data quality at each iteration of test load
Evaluate Data Quality
• Improve process and data; solidify submission process• Be clear on ownerships
Define Cleansing and Governance Process
• Submission handling, and approval concept• Integration strategy
Define submission procedure and triage
concept