Manufacturer Master Data

Transcription

1 Manufacturer Master Data December 1, 2011 Jackie Elkin, Medtronic, Inc. Slide 1

2 What is Master Data? Master Data, which may include reference data, is information that is key to the operation of business and is the primary focus of the Information Technology (IT) discipline of Master Data Management (MDM). May include data about customers, products, employees, materials, suppliers, etc. which often turns out to be non-transactional in nature. Often used by several functional groups and stored in different data systems across an organization and may or may not be referenced centrally; therefore, the possibility exists for duplicate and/or inaccurate master data. Master Data is that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the organization. Slide 2

3 UDI Data Elements Item Master PLM / Labeling Regulatory Unique Device Identification Code / GTIN Trade/Brand Name Device Product No. (REF) Product Description Unit of Measure and Quantity (parent / child) MDM/R3 Controlled by: Serial, Lot/Batch, Mfg Date, Exp Date Size, Weight and Other Critical Clinical Attributes as Defined (description) Storage Conditions (as labelled) Temp, Humidity, etc. Labelled as Single Use Yes/No Package Sterile Yes/No Need to be Sterilized Before Use Yes/No Labelled as Containing Latex - Yes/No Market Authorization No. Manufacturer Listing No. Nomenclature GMDN DUNs No. Slide 3

4 MDM Strategy Components Data Standards Data Processes People & Governance Tools and Technologies Slide 4

5 MDM - Data Standards q Data elements are defined and documented Policy and Procedure q Standards apply across enterprise systems and processes q Compliance is measured and audited q Address the Rules of Interchangeability (when do you need a new identifier?) Slide 5

6 Example Product of Interchangeability Data HierarchyRules Level Data-grouping Tool Marketing or Regulatory Identifier PRODUCT ATTRIBUTES q Model Number q Model Description q Brand Name PRODUCT IDENTIFIER Model Number ACTIVITIES DRIVING IDENTIFIER CHANGES q Major Product Changes Product/Service Sales/Marketing q REF Number q REF Number Description REF Number q New Non-Interchangeable, Orderable Product Form, Fit, Features or Functions Production Level / Commerce Level qlanguage qmarket qpackage Config. qpackage Marks /CE UDI GTIN / HIBC qnon-interchangeable Label/Pkg. Config. - Language, Market, Release, Package Mark Differences qunit of Measure qpackage Quantity qpkg Lev: New Package Quantity Offered Slide 6

7 MDM - Data Processes q Establish Governance / Data Administration processes are documented and clear q Individual accountabilities are known and executed Data Stewardship q Processes extend across businesses, functions and geographies q Processes are inclusive of master data lifecycles (product lifecycle) & multiple systems Slide 7

8 MDM People & Governance q Data Administrators and Stewards (functional experts) are named, trained and empowered q Data Managers and Councils are established, meeting regularly and resolving issues q Executive management recognizes and supports MDM initiatives Slide 8

9 MDM Tools & Technologies Technology is one key component of effective MDM. q Facilitates the creation/maintenance of data (cleansing, matching, de-duping, synchronization). q Provides integrations with ERP, CRM, EDW, 3rd party data, etc. q Serves as a vehicle for auditing, collecting metrics, and measuring compliance to standards. Slide 9

10 UDI Data Consolidation using MDM Tools / Technology Master data consolidation: Use data models to aggregate master data from disparate sources into a central repository Master data harmonization: Cleanse, match and merge, deduplicate and normalize master data to ensure data quality Master data synchronization: Deliver synchronized master data to client applications across heterogeneous systems Slide 10

11 Master Data Sources Data Consolidation Regulatory UDI Data Sources & Consolidation Options ERP Product Data PLM & Label Data Multiple systems PLM & Label Data Multiple systems PLM & Label Data Multiple systems Data Warehouse Data Stores MDM Tools Regulatory Product Data Information Space Other Apps UDI Submission process FDA UDI DATABASE Slide 11

12 Master Data Sources Data Consolidation ERP Product Data Regulatory Product Data Information UDI Data Sources & Consolidation Options PLM & Label Data Multiple systems UDI Submission process FDA UDI DATABASE Slide 12

13 Who Needs to be Involved? Regulatory Quality Manufacturing / Labeling / Technical Publication Configuration Management Operations Supply Chain Customer Service Information Technology Slide 13

14 Thank You Jackie Rae Elkin Global Process Owner - Standard Product Identification Medtronic, Inc. Global Regulatory Operations 710 Medtronic Parkway, LS 330 Minneapolis, MN USA Office: Mobile: [email protected] Slide 14