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Copyright © 2019 TraceGains, Inc. All rights reserved.
Best Practices in Regulatory-Document Management Implementation
Wi-fi Network: TraceGains User ConferencePassword: tgcon2019
Download the mobile app to ask questions during the class, answer polls, and review the training after the session.https://event.crowdcompass.com/tgcon2019
9:30 – 10:15 am
Sue Huske | Consultant, ESB Compliance Partners LLC
Best Practices in RegulatoryDocument Management Implementation
Personal Background in the Food Industry• Quality Analytical Specialist• Territory Sales Manager
• Regulatory Specialist• Regulatory Manager• Executive Manager- Quality & Regulatory
• Senior Regulatory Manager• Consultant / TraceGains Program Partner for implementation
success
Document Compliance: Assuring Customer Success• Document Management: the
process of storing, locating, updating, and sharing data for the purpose of workflow progression and business outcomes
• Customer: the recipient of a good, service, product or an idea obtained from a seller, vendor, or supplier
• Success: the accomplishment of an aim or purpose
New Product Development Life Cycle
ANDThe paper trail that
follows it
Key Steps to Assuring Success for the Customer and Company
Documentation
Customer Idea
R & D
Finance & Procurement
Quality & EHS
Regulatory
Customer
New Product Development Life Cycle
Customer Idea Customer contacts company with
a new concept for product development
Customer has a fast timeline for project completion due to their customer’s requirements
Food service projects are fast paced and the quicker a new product can get to market the more likely a company is to gain the business
Documentation
Customer Idea
R & D
Finance & Procurement
Quality & EHS
Regulatory
Customer
R&D- Product Development What are the customer’s requirements?
(Kosher, Halal, Allergen Free, Gluten Free, Natural…..)
Are ingredients/supplier already approved internally?
Is the new ingredient commercially available from supplier?
What are the attributes of the ingredient? - (Powder, liquid, solubility…..)
Documentation
Customer Idea
R & D
Finance & Procurement
Quality & EHS
Regulatory
Customer
Finance & Procurement
What does it cost to manufacture new product?
Price of ingredients?
Name of ingredient and supplier’s item code to enter in ERP system
Documentation
Customer Idea
R & D
Finance & Procurement
Quality & EHS
Regulatory
Customer
Quality & EHS Allergen Statement - does the product
contain allergens?
Safety Data Sheet - Are all the new ingredients safe to use?
Audit Certificate and Report – Is the manufacturer/supplier GFSI certified?
Specification - How do new ingredients need to be stored?
Documentation for GFSI audit
Supplier risk? – Does the supplier need to be audited?
Documentation
Customer Idea
R & D
Finance & Procurement
Quality & EHS
Regulatory
Customer
Regulatory What are the customer’s requirements?
(Kosher, Halal, Allergen Free, Gluten Free, Natural…..)
Are all of the ingredients approved for food use?
Regulatory Document Creation: Specifications Nutrition Allergen Country of Origin GMO Labeling
Documentation
Customer Idea
R & D
Finance & Procurement
Quality & EHS
Regulatory
Customer
Customer Customer receives finished product
and regulatory documentation
Quick turn-around from concept to delivery increases chance customer return for future projects
Customer places order
Documentation
Customer Idea
R & D
Finance & Procurement
Quality & EHS
Regulatory
Customer
Document Management Evolution
File Cabinets Electronic Files Spreadsheets Cloud-based Systems
Document Management Implementation
Choosing the right document management system
Implementation
Collaboration among departments
Selecting the Right Document Management System
• Research product options
• Schedule demos
• Cost analysis
• Customer testimonials
Implementation of Document Management System Internal Staff or Consultant?
Time Frame
Gathering of Supplier Information
Gathering of Ingredient Information
Upload
Training / Navigating the system
Collaboration
• Intercompany departments
• Ownership, Board and management
• Suppliers
Regulatory & Compliance Solutions
TraceGains Software Implementation
Supplier Relationship Management
Specification Creation
Regulatory Document Creation
Questions?
Thank You
