it's a lot to know everything about your lot
TRANSCRIPT
SAGE NORTH AMERICA
It’s a Lot to Know Everything
About Your Lot
SAGE NORTH AMERICA
Who are we?
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Southeast Computer Solutions has been helping small to medium sized businesses get the most suitable business management software to run their operations since 1985.
With over 1000+ Sage software installations and implementations across the United States, Caribbean and Latin America, we have become one of the largest and most reputable Sage business partners in South Florida.
What do we do?Southeast Computer Solutions offers its clients expert technology consulting advice based on best practices. We listen to you and provide our best thinking solutions to meet your needs.
We help clients by performing business analysis & offering our expert consulting advice. Client’s enjoy a professional and fun experience throughout our implementations, trainings, and support.
Our office located in Miami Lakes, FL
SAGE NORTH AMERICA
What our clients want to know…
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• What is FDA validation?
• How can my system be FDA validated?
• How does the Food Safety Modernization Act impact my business?
• How do I comply with GMO labeling?
• How do I handle a mock recall successfully?
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It’s a lot to know everything about your lot!
• What is FDA Validation?•How can my system be FDA validated?•FDA validates “process”, not “software”
FDA Validation (Compliance)
•Food Safety•Transparency•GMO Labeling•Waste & Spoilage
Food Safely Modernization Act (Compliance)
•Lot Traceability•Barcoding•Electronic Signatures (Approvals)•Workflows
How can technology help?
•Recipe and Formula management•Lot and Batch processing
Process vs. Discrete Manufacturing
•Tools and Deliverables•Case Studies
Where do I go from here?
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FDA Validation
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What is FDA Validation?
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There are many industries that are regulated by the FDA. These include:
• Food & Beverage manufacturing• Pharmaceuticals• Medical Devices• Tobacco• Cosmetics• Vaccines• Animal & Veterinary• Radiation-Emitting products
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What is FDA Validation?
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• What is the Code of Federal Regulations (CFR)?
• How is it “enforced”?
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What is FDA Validation?
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From a validation perspective, most life science manufacturing businesses only need to concern themselves with:
• Part 11 (Electronic Signatures)
• Part 820 (Quality Systems)
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How can I get my system validated?
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• In January 2011, the FDA published its long awaited “Guidance for Industry – Process Validation: General Principles and Practices”
http://www.fda.gov/downloads/Drugs/Guidances/UCM070336.pdf
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Food & Safety Modernization Act
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What is the FSMA?
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• What is the Food and Safety Modernization Act (FSMA)?
• The FSMA greatly expands the powers of the FDA to mandate traceability, documentation and inspections.
• The FDA conducted more than 20,000 inspections in FY 2011, and that number doubled to over 40,000 under FSMA.
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What is the FSMA?
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• Food Safety
A number of high-profile recalls have resulted in numerous illnesses and deaths in recent years.
Recent large-scale outbreaks and recalls have been associated with:
• Cantaloupe• Eggs and Egg products• Cookie Dough• Ground Beef
50% of food borne illness outbreaks come from imported food.
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What is the FSMA?
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• Transparency
The FSMA drives an increasing mandate for food companies to be transparent about their sourcing, ingredients and processes.
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What is the FSMA?
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• GMO Labeling
As much as 93% of consumers say they favor labeling of genetically modified organisms (GMO’s) in food
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What is the FSMA?
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• Waste & Spoilage
Factors that produce inefficiency through food waste include expiration and cross-contamination with allergens.
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Process vs. DiscreteManufacturing
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Process vs. Discrete manufacturing
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Now that we understand some general business challenges, what system is best suited for my industry?
• Discrete manufacturing is all about assembling “things”
• Process manufacturing is all about making “stuff”
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Process vs. Discrete manufacturing
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Formula & Recipe Management
• Multiple units of measure• Yields and potencies• Quality processes
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How can technology help?
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How can technology help?
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Manufacturing companies are increasingly under more pressure to be compliant.
This can be done through a combination of features:
• Lot traceability• Barcoding• Electronic Signatures (Approvals)• Workflow
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How can technology help?
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Lot traceability
Many ERP systems these days offer lot tracking as part of their inventory control or inventory management modules.
• Lot traceability for Quality Control
• Lot traceability for Recalls
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How can technology help?
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Barcoding
• Real time data capture
• Reduce errors
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How can technology help?
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Workflows
• Control Data/Information flow
• Ensure everyone follows same procedure
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How can technology help?
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Electronic Signatures (Approvals)
• Accountability / Traceability
• Electronic Signatures also help comply with CFR 21 Part 11
