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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

Sue L. HuskeESB Compliance Partners LLC

shuske@att.net +1-920-905-2008

Regulatory & Compliance Solutions

TraceGains Software Implementation

Supplier Relationship Management

Specification Creation

Regulatory Document Creation

Questions?

Thank You