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Checklist of Minimum Components for a Zero Defect Enterprise Labeling System

 

Component

Description

Design

A comprehensive label design module with built in ERES and audits

Workflow

Label life cycle work flow integrated with the design module compliant with regulatory specifications

ERES Certification

Electronic Records and Electronic Signatures Compliance integrated with components

Security

System security and authentication as per closed system specifications -- One security for all components

Approval

Label approval module offering a tightly integrated process with the design module

Electronic Messaging

Automatic email notification and messaging integrated with the overall process

Quality Assurance

Label review & quality assurance module and process tightly integrated with design and approval

Production Printing

Plant visible front ends to offer error free label requisition and error free operator interaction

History and Reports

Audit trails and full reporting capabilities integrated in the closed system

User Classification

Managing users, authentication and authorization levels with built in utilities that offer closed system compliance

Approval Authentication

Managing approval groups and routings integrated with the design, approval and QA modules

Verification

Base line setting and management for QA and archival to insure system integrity

Connectivity

Modules to interface ERP and other business systems to ensure corporate data integrity; Also offer secured and compliant Web enabled accessibility

Trace ability

Lot number, manufacturing date code, and best use date management for maximum reliability

International

Offer technological compliance for multilingual applications and markets

Synchronization

Multilevel synchronization to assure continuous processing

Quality & Validation

IQ, PQ and OQ plan, script and documentation to assure system validation and proof of performance

 

 

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Tattoo ID ® bar code labeling software is a trademark of Integrated Software Design, Inc.
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