The information in this proposal may not be disclosed outside of Wright Medical Technology (or associated companies. and may not be duplicated, used or disclosed in whole or in part for any purpose other than to evaluate the proposal, provided that if a contract is awarded to Sensei Regulatory Compliance as a result of or in connection with the submission of this proposal, Wright Medical Technology will have the right to duplicate, use or disclose the information to the extent provided by the contract. This restriction does not limit the right of Wright Medical Technology to use information contained in this proposal if it is obtained from another Prepared for: Wright Medical A Response to Wright’s Medical Technology, Inc. UDI Compliance and GS1 Adoption Implementation BY:
Transcript
The information in this proposal may not be disclosed outside of Wright Medical Technology (or associated companies. and may not be duplicated, used or disclosed in whole or in part for any purpose other than to evaluate the proposal, provided that if a contract is awarded to Sensei Regulatory Compliance as a result of or in connection with the submission of this proposal, Wright Medical Technology will have the right to duplicate, use or disclose the information to the extent provided by the contract. This restriction does not limit the right of Wright Medical Technology to use information contained in this proposal if it is obtained from another source without restriction. Sensei Regulatory Compliance retains ownership of this proposal.
This proposal is valid for 30 days from the date above.
Prepared for:
Wright Medical Technology, Inc.
A Response to Wright’s Medical Technology, Inc. UDI Compliance and
GS1 Adoption Implementation
BY:
Sensei Regulatory Compliance
September 17, 2014
XXXXXWright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Dear XXXX,
Sensei Regulatory Compliance is pleased to submit our proposal to assist Wright Medical Technology with the global UDI compliance and GS1 adoption project. Sensei Regulatory Compliance brings deep expertise in UDI Compliance, GS1 Implementation, Healthcare Supply Chain Management, Medical Device manufacturing industry and in ERP systems upgrades and rollouts. We would bring the best and brightest IT Regulatory consultants to Wright Medical Technology, Inc. with this ERP/ Labeling compliance initiative.
Just as two of Wright Medical Technology, Inc., assets are your people and customer relationships; the same is true for Sensei Regulatory Compliance. As a customer of Sensei Regulatory Compliance, you can be assured our team will work to satisfy you on a daily basis. Our experienced consultants and leadership team will be singularly focused on delivering together with your team, a solution that meets or exceeds your expectations. At Sensei Regulatory Compliance, we measure our success based on our customers’ success.
Medical device manufacturing companies like Wright Medical Technology, Inc. are significant to Sensei Regulatory Compliance because of industry alignment and the size of your organization. As such, we will continue our commitment to delivering value to Wright Medical Technology, Inc. during this project. As a senior member of our Compliance Consulting practice, I am personally committed to the success of this initiative.
In this proposal and the associated appendices, you will find that we have provided recommendations to ensure timely compliance to the UDI regulations and GS1 adoption while ensuring that the approach that is taken is streamline to reduce cost and focused on meeting Wright Medical Technologies needs. As your preferred partner for this initiative we will provide value to your organization which will be evident as you review this proposal.
As an officer of Sensei Regulatory Compliance, I am authorized to address any contract related items and I will be the primary point of contact for any questions related to our proposal. I can be reached at (574) 386-7732.
We look forward to presenting our proposal and earning your business.
Sincerely,
Victor RodgersPresidentSensei Regulatory Compliance P: 574-386-7732
Executive Summary
Sensei Regulatory Compliance is pleased to present our response to Wright Medical Technology’s RFP and to demonstrate our strong commitment to assisting Wright Medical Technology with this strategically important compliance project. Our response is designed to provide the information Wright Medical Technology requests and to illustrate our interest in working with you.
It is understood that Wright Medical Technology currently is working with JD Edwards Enterprise One as their global enterprise application solution, but has also acquired Master Control’s Document Module to handle labeling of the products.
We have listened well and heard that Wright Medical Technology leadership is looking for compliance to UDI and that assuring GS1 readiness will help satisfy numerous customer concerns about compliance.
Sensei Regulatory Compliance has built our UDI / GS1 Compliance project approach, implementation methodology, work plan, key risks and cost estimates based upon our experience and what we believe is required to make the project successful. We have attempted to integrate the information we have received from Wright Medical Technology as well as from JD Edwards and Master Control Solution engineers. Sensei Regulatory Compliance is committed to Wright Medical Technology’s overall goals for an enterprise business transformation and will engage in the compliance project leveraging our prior project experience, industry best practices and implementation methodology to create a cost effective and timely implementation solution. We will support this effort with proven tools and templates, training and guidance, and collaboration with the Wright Medical Technology team.
Sensei Regulatory Compliance has substantial experience with Healthcare Supply Chain Management, Medical Device and in ERP systems upgrades and rollouts in the Manufacturing industry. In addition, we have worked with businesses similar to Wright Medical Technology, global with a presence in US, China and Europe. Sensei Regulatory Compliance will work closely with the Wright Medical Technology’s team to install, educate, design, configure, address interfacing requirements, and roll out (e.g. localize, load data, train, cutover to production and “Go Live” support) any changes to the ERP system due to the UDI and GS1 adoption impact to either JD Edwards or Master Control.
We consider this initiative to be far more than a technology implementation effort. We view this strategic endeavor as a business transformation initiative in which Wright Medical Technology, Inc. will position itself to maximize its resources to better serve customers while more effectively managing the business. We have built our project approach, work plan, and cost estimates based upon the identified project needs and within the timeline and manner requested. This focuses our organization on you, the voice of the customer. To ensure proper delivery of outcomes
During any ERP implementation there is a certain amount of organization chaos. Systems are being switched out, there is a lot of training, people are learning new skills and processes, and the company is going through some level of cultural change.
The Business Intelligence Blueprint process is design to ensure management continues to have the information they need to in order to drive results. Sensei Regulatory Compliance’s goal is to shield management, and assist in their ability to make effective decisions, during the period of chaos.
Sensei Regulatory Compliance’s Business Intelligence Blueprint Methodology is a highly structured process that has evolved over the last eight years and been successful for many clients across multiple industries. Its components include:
1. Strategy - are the high-level objectives clearly described?
2. Process - are core processes effective and efficient?
3. Metrics - are the right mix of measures utilized?
4. Data - is the data required to support decision-making available?
5. Applications - does software enhance core processes?
6. Architecture - is the correct infrastructure in place?
7. People - is human and organizational capital appropriate?
Quality Management & Barcode and Labeling
Quality Management Processes will be an integral component of the successful deployment of meeting compliance to the UDI and implementing GS1 readiness at Wright Medical Technology. Throughout the project, it will be important to define how ERP solution features/functions should be effectively phased in for each Wright Medical Technology business. We have focused on the key areas that were described as mission critical to helping Wright Medical Technology achieve desired business benefits. We recognize that it is critical to maintain a validated system, define a plan for updating to GS1 readiness following key concepts that are identified by GS1 Standards.
(Examples of Key concepts are below):
There are over 100 Application Identifiers (AI) Each Application Identifier (AI) has a two, three, or four digit numeric Prefix in front of the
data to tell what the data means. For example, the AI for Serial Shipping Container Code (SSCC) is (00) and for: Global Trade Item Number (GTIN) it is (01)
GS1-128, GS1 Data Bar, GS1 Data Matrix, GS1 QR Code and Composite Component can carry AIs
More than one AI can be carried in one bar code. When this happens, AIs with a fixed length data content (e.g., SSCC has a fixed length of 18 digits) are placed at the beginning and AI with variable lengths are placed at the end. If more than one variable length AI is placed in one bar code, then a special "function" character is used to tell the scanner system when one ends and the other one starts.
Each bar code has a corresponding text line for the encoded AI(s). The AI Prefixes appear in parentheses - e.g., GTIN (01)10614141000019
Several AIs are used for the GS1 Identification Keys (examples include: Global Trade Item Number (GTIN), Global Location Number (GLN), Serial Shipping Container Code (SSCC), etc.)
AIs exist for trade item attributes, such as: variable count, net weight, lot number, and expiry date
AIs exist for logistic unit attributes, such as: count of trade items contained, gross weight, gross volume, routing code, etc.
The balance are used for special purposes, for example: Shipment Identification, Consignment Identification, Couponing, Refund Receipts, Electronic Serial Identification for Cellular Mobile Telephones, Internal Use, Payment Slips, and Customer Specified Articles, etc.
High Level Phase Approach to comply to GS1
During Phase One, sourcing legacy UDI attribute data from multiple sources can occur thru automated process, which can expedite this effort and improve data accuracy compared to manually searching for this information and compiling it into spreadsheets. Utilizing Enterprise Data Quality (EDQ), multiple data sources (i.e. ERP, MES, RA databases, etc.) can be automatically searched for attributes and aggregated for all legacy SKUs. Inconsistencies in attribute taxonomy (i.e. description & UOM) should be identified to be cleansed, validated and shaped into a standard format for enterprise synchronization with all GTINs. This process can save significant labor, improve data integrity and establish enterprise standards for all UDI attribute taxonomy.
During Phase Two UDI attribute data that has been collected and cleansed must be managed under FDA 21 CFR part 11-revision control and synchronized with each SKU/GTIN to provide an auditable archive. In addition, the UDI (D.I) attributes associated with the “unit of use” for each product must be managed across multi-level packaging hierarchy configurations to support enterprise use of this critical data. Prebuilt UDI attribute templates with configuration rules and change management functionality support management of this data in a structured format, and provide an auditable archive to support regulatory compliance.
Registration of product UDI (D.I.) attributes to the UDI database must be organized in a Structured Product Label (SPL) format and transmitted to the FDA using an HL7-XML protocol.
Solution Architecture
In addition, Sensei Regulatory Compliance solution provides a foundation for additional business processes such as label change management, enterprise quality management (EQM), product registration synchronization, and DHF/DMR management.
