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Welcome to…Is Your Company Compliant?
Is your company meeting it’s regulatory and customer obligations
Hosted By: SBS GroupPresented By: Paul Silvani, Process Manufacturing ExpertDate: August 2, 2011
Today’s Agenda• Introductions• Discussion on Compliance• Demonstration • Questions & Answers• Next Steps
Process Mfg - Webinars
• Continuing Webinar Series for process manufacturers– Streamline Formula Management – Is Your Company Compliant?–Managing Samples in CRM
• Please send feedback for possible topics
SBS Group Overview• Founded in 1986• 15 U.S. Offices• Microsoft Inner Circle Member• Microsoft Gold Certified Partner
– Gold Competency in Microsoft Dynamics– Silver Competency in Portals &
Collaboration– 2007 Microsoft Partner of the Year
(Dynamics SL)• Industry Focus in Process Manufacturing • 800+ Microsoft Dynamics, Sage PFW &
Sage MAS 500 clients• Software Solutions including Vicinity
Manufacturing, Microsoft Dynamics AX, Dynamics CRM, Dynamics SL & GP, Sage PFW
Industry Focus: Process Manufacturing
Software Solutions for Process Manufacturing• Vicinity Manufacturing/Great Plains/Solomon• Microsoft Axapta• Microsoft CRM• Sage PFW (Chicago Office)
Strategic Vertical – Process Manufacturing• End to End Solutions for Process Manufacturers• Provide greater insight to your organization• Have the experience, resources, technology and
locations to assist
Introduction: Paul SilvaniSpeaker – Paul Silvani
Practice Manager – SBS Group• Over 20 years working with process
manufacturers• Both corporate and consulting roles• Founder of Vicinity Manufacturing• Served on BatchMaster Advisor board• Founder of Lakeshore Consulting
Paul Silvani
Not a regulatory expert
Working with the industry and knowledgeable about what
companies require
What does Compliance mean?
• Conformity; Accordance
• Cooperation
Dictionary.com
What does Compliance mean?• Conformity; Accordance
• Standardization and commonality of information and formats
• Cooperation
• Willingness on the part of the organization to share this information
What does Compliance mean?
• Legal - MSDS• Customer -Product Spec, C of A•Other – Lot tracking
Why is it important?
Big BrotherLaw
El FederalesUncle Sam
Why is it important?
Your Customer requires information
Why is it important?
Safety!!!
Why is it important?
“Resistance is futile!”Borg - Star Trek Next Generation
Material Safety Data SheetWhat is it?
Form with data regarding the properties of a particular
substance.Important component of
workplace safety
Material Safety Data SheetFormats
• 16 Section (US)•Globally Harmonized System• Canadian• Full Disclosure
Material Safety Data SheetWhat should go on it?
• Legal Requirements• What you are comfortable providing• Graphics• Accepted standards such as UN numbers,
CAS numbers, DOT Codes
Material Safety Data Sheet
Example
Product Spec Sheet
Written Statement of an item’s required characteristics
documented in a manner that facilitate its procurement or production or acceptance.
BusinessDictionary.com
Product Spec Sheet• Normally 1-2 pages• Take QC specifications• General info on a the product• Standard phrases associated with the
product or application• Based upon standard attributes of product
Certificate of AnalysisAuthenticated document,
issued by an accredited firm or individual, that
certifies the quality and purity of the product.
BusinessDictionary.com (and yours truly)
Certificate of Analysis• Normally 1-2 pages• Take actual QC results• General info on a particular lot of the
product• May incorporate customer information• Based upon actual results of the product
Certificate of Analysis
Lot TracingAbility to record and recall all items and specific lots which came into the facility and identify where they went.
• Bottom Up• Top Down
Compliance Systems
Requirements for a Good
System
Compliance SystemsRequirements for a Good System
• Store information (Lots of it)• Share that information • Able to draw upon existing information• Ability to tailor to your requirements• Generate multiple formats
How to cope with compliance
Material Safety Data SheetThe Right First Step
Compliance Systems
Applications like Vicinity put emphasis on organization to gather
information and define requirements.
Other applications in the market which have regulatory information
and content available
Review of Solution
• What is Compliance• Material Safety Data Sheets• Product Spec Sheet• Certificate of Analysis• Lot Tracing
Next Steps…SBS Group
Contact: Paul SilvaniPhone:312.254.0808Email: [email protected]
Contact: Kim KohlheppPhone:732.476.5909Email: [email protected]
Next Steps…SBS Group
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