• Product Lifecycle Management

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A Scalable Single Source of Truth for Product Master Data

Building a High-Capability Solution to Support Massive Data Growth

Problem:

  • Inability to provide upcoming product master data is a significant threat to commercial operations
  • Current processes, systems, and personnel cannot scale to meet significant growth in data
  • Multiple product master data repositories in use; not integrated; data not consistent across systems
  • Expected exponential growth in Data Points from future regulatory and customer requirements
 One Data Point = 1 Product Data Attribute for a single product packaging level   
 Example: each UDI country regulation expected to require 10-20 new data attributes     
 6 pending UDI initiatives + 28 EU countries yields between 350-700 new attributes for every product (current and future)

 

Solution:

Our solution provides a scalable Single Source of Truth for product master data.

Why does this matter? Product Master Data is the ‘fuel’ that powers the enterprise, and is required to conduct every commercial product transaction starting in R&D, through manufacturing and supply chain, financial reporting, and quality reporting. Without accurate product master data, an organization cannot function effectively, if at all. Until recently, thin or inaccurate or incomplete product master data could be worked around, but the increasing growth of mission-critical regulations and customer requirements make this impossible. For example, if accurate data is not provided to FDA systems for UDI, your product is mis-branded and subject to regulatory action.

How do we do this? Our experts are deeply involved with the evolution of the global regulations and customer requirements, and can quickly translate these requirements into tangible deliverables. We are system-agnostic, and work within your current or planned framework to address these new needs.

One key focus area is the collection of the necessary attribute data to populate the data model. In our experience, up to 80% of the necessary data is not available in an electronic system or is not trustworthy, and must be manually captured, cleansed/enriched, reviewed, approved, and loaded. We are familiar with a variety of systems and issues that can slow this process. A key goal is to maximize productivity to ensure the growth of resources is far below the growth of data points managed.

We use a 4-step methodology to deliver solutions quickly and in a phased, risk-based approach.

PLM 4 Step Method

Assess:

Working with your key internal and external stakeholders, we assess your current product master data systems, responsible organizations, and their governance and maintenance processes. We also define the needed current and future attributes to meet regulatory and business needs, and outline the gaps. The results are presented in a management summary report.

Roadmap:

Based on the findings in the management summary report and the feedback received, USDM will conduct a strategy and roadmap exercise to define solutions to the identified gaps and needs. The roadmap describes the necessary data models, solution stack, integrations, governance and maintenance processes, human resource needs, training requirements, cutover plan, data migration plan, validation activities, and overall budget. The results are presented in a management summary report. Other deliverables include a Requirements Specification and Budget recommendations.

Select and Acquire:

USDM will assist you in creating RFP’s, vendor selection processes, contract negotiations, and acquisition of the necessary tools.

Build and Deploy:

USDM builds the implementation and validation plan in a phased, risk-based approach, then oversees and executes the implementation and validation activities to deliver your solution quickly and within budget.We bring unique insights to our life science partners as we work with manufacturers, distributors, healthcare providers, and regulators. We are familiar with, and partner with, the leading software providers to bring you a full-featured, compliant, and scalable solution.

Pictorial Representation:

PLM Product Master Data Landscape

PLM Single Source of Truth

This is a complex journey and you need an experienced guide. We help you achieve productivity gains that minimize your headcount growth. We build capabilities, so future requirements can be quickly absorbed without needing a costly project. We help you delight your customers with accurate, timely data while also assuring your ability to provide regulatory data to the authorities. Highlighted below are some real-life results:

  • Attribute growth of 200% offset by productivity gains of 80% or more; minimal headcount increases needed
  • Scalable model delivered capable of >3,000% growth in attributes and data points
  • Single Source of Truth assuring alignment between internal and external systems

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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