Atl Security Label Systems Slideshow
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Transcript of Atl Security Label Systems Slideshow
Who Is ATL?
• Label printer and converter in Menomonee Falls, WI
• FDA Registered Medical Device Manufacturer
• cGMP Compliant to 21 CFR 210, 211 & 820
• 55 year old company
What makes ATL different?One word:
Quality
What exactly is “Quality”?At ATL:
Quality means conformance to requirements.
How is this done?
Through Quality Assurance
Quality Assurance at ATL
• Six Sigma Black Belt experience
• Certified Security Personnel
• Ongoing Systems Validation Protocol
Total Conformance: 2007 99.97%2008 99.98%2009 99.95%
Steps ATL takes to ensure Quality is built into the product…
Quality Management System
A Quality Management System (QMS) is a capable and controlled (written) manufacturing system.
An effective QMS eliminates most failures before they occur. This is done through a technique called Failure Modes & Effects Analysis (FMEA).
FMEA
The FMEA identifies what controls are placed in the production process to catch any defects at various stages in the processing.
FMEA has been used by the U.S. to get a man safely to the moon and back.
At ATL, FMEA is done through…
Audits
Audits are not only done internally, but also externally.
ATL will audit potential customers before developing a security product.
ATL is just as cautious about whom we are working for as you are when selecting your suppliers.
Audit ProcessFlowchart: Security Job Flow
Audit ProcessFlowchart: Part One – Security Questionnaire
• Send questionnaire to customer
• Answers sent back for evaluation
• ATL auditor determines legitimacy
• Job is denied or moves forward
Audit ProcessFlowchart: Part Two – Security Questionnaire
• Talks begin between customer and ATL
• Customer’s needs are determined: Overt, covert, track & trace, etc.
• ATL performs security audit of customer’s facility/ distribution center
Audit ProcessFlowchart: Part Three – Security Questionnaire
Audit may include the following:
Contract ReviewTraceability throughout systemSystems Validation ProtocolTraining recordsStockroom controlsTraveler with QA sign-offsInput / Output controls including wasteQA internal auditsSecure entrances
Audit ProcessFlowchart: Part Four – Security Questionnaire
If audit is successful:
Project moves forward to Engineering
Audits at ATLATL’s Audit History:
ATL’s facility and staff have successfully passed eighteen on-site ISO-9000 and cGMP compliance audits from pharmaceutical and medical companies since November 2000. Companies include:
NovartisBristol-Myers Squibb (BMS)Sanofi-Aventis Abbott Laboratories PfizerJohnson & Johnson Eli LillyGE MedicalSchering-Plough
Audit Results and Comments:
• No critical findings EVER
• Professional staff supportive of audit activities
• Company president actively involved in audit
ATL Security Label System’s Available Services
Brand Protection / Security
• Supply Chain Management and Auditing
• Loss Prevention Assistance
• Overt and covert security label features including…
Brand Protection / Security
Invisible Digital Forensic Marking
Track and Trace: Serialization, Custom Codes,
2D Barcodes
Brand Protection / Security
Authentication/Tamper Indicating
The PocketSureTM reading device uses proprietary
algorithms configured by InkSure Technologies to detect
the hidden code or image. Each code is unique.
Covert Marking or Taggants in Ink or Varnish
Brand Protection / Security
Hidden Scrambled Indicia Technology
• Hidden indicia is encoded in layers or in the varnish.
• Easily incorporated into any design.
• Decoded with an optical lens, proprietary software, or iDetector Mobile Authentication Device. Example of printed
layers
Example of optical lens decoding hidden message
Engineering Services
• Personal and confidential engineering assistance• Design for manufacturability and cost reductions• Rapid and cost effective prototypes
Label Capabilities
• Multi-Panel Booklets, 3-35 Pages• Wrap-Around Construction for Small Cylinders• Folded and Extended Content Labels• Scratch Offs• Cold Foil Printing
Other Capabilities
• Custom die cut components• Laminating multiple materials together• Island placement• Cold seal pouching, packaging and kitting
ATL Security Label SystemsW140 N9504 Fountain Blvd.
Menomonee Falls, WI 53051800-444-5144