Loading
Rockwell Automation Home
  • Industries
    • Industries Chevron RightChevron Right
      • Automotive & Tire
      • Cement
      • Chemical
      • Entertainment
      • Fibers & Textiles
      • Food & Beverage
      • Household & Personal Care
      • Infrastructure
      • Life Sciences
      • Marine
      • Metals
      • Mining
      • Oil & Gas
      • Power Generation
      • Print & Publishing
      • Pulp & Paper
      • Semiconductor
      • Water Wastewater
      • View All
    Industries
    Case StudyRockwell Automation's case studies Case Studies DistributorDistributor How to Buy EventEvent Events
  • Capabilities
    • Capabilities Chevron RightChevron Right
      • The Connected Enterprise®
      • Consulting & Integration Services
      • Cybersecurity
      • Digital Transformation
      • Industrial Analytics
      • Industrial Automation & Control
      • Industrial Maintenance & Support
      • Industrial Networks
      • Lifecycle Services
      • Machine & Equipment Builders
      • MES Solutions
      • Process Solutions
      • Safety Solutions
      • View All
    Capabilities
    Blogs DistributorDistributor How to Buy EventEvent Events
  • Products
    • Hardware Chevron RightChevron Right
    • Software Chevron RightChevron Right
      • Circuit & Load Protection
      • Condition Monitoring
      • Connection Devices
      • Distributed Control Systems
      • Drives & Motors
      • Energy Monitoring
      • Human Machine Interface
      • Independent Cart Technology
      • Industrial Computers & Monitors
      • Input/Output Modules
      • Industrial Control Products
      • Lighting Control
      • Motion Control
      • Motor Control
      • Networks Security & Infrastructure
      • Packaged Solutions
      • Power Supplies
      • Programmable Controllers
      • Push Buttons & Signaling Devices
      • Relays & Timers
      • Safety Instrumented Systems
      • Safety Products
      • Sensors & Switches
      • Signal Interface
      • View All Hardware Products
    • DesignSuite
      • Dynamic Digital Twin Software
      • Studio 5000 Design Software
    • OperationSuite
      • FactoryTalk Edge Gateway
      • FactoryTalk Batch
      • FactoryTalk Historian
      • FactoryTalk View - HMI Software
      • FactoryTalk Metrics
    • MaintenanceSuite
      • FactoryTalk Analytics for Devices
      • FactoryTalk AssetCentre
      • FactoryTalk Emonitor
      • FactoryTalk Network Manager
      • FactoryTalk TeamONE
      • Fiix CMMS
    • InnovationSuite
      • Augmented Reality
      • FactoryTalk Analytics
      • MES
      • ThingWorx IIoT Platform
    Products
    Find Products by Our Brands: Allen-Bradley FactoryTalk
  • Support
    • Product Support Chevron RightChevron Right
    • Documentation Chevron RightChevron Right
    • Knowledgebase Chevron RightChevron Right
    • Training Chevron RightChevron Right
    • Downloads
      • 2D & 3D Drawings
      • Activations
      • Add-on Profiles
      • Application Code Libraries
      • Compatibility & Downloads
      • Drivers & Firmware
      • Electronic Datasheets
      • EPLAN Macros
      • Sample Code Library
      • Software Patches
      • View All
    • Selection & Configuration
      • Control Systems Configuration Tools
      • Procurement Specifications
      • ProposalWorks Proposal Builder
      • Global Short-circuit Current Ratings Tool
      • Integrated Architecture Builder
      • View All
    • Compatibility & Migration
      • Migration & Modernization
      • Lifecycle Status
      • Product Replacement Lookup
      • View All
      • Technical Documentation Center
      • Technical Specifications
      • Product Certifications
      • Product Drawings
      • Release Notes
      • Literature Library
    • Support Center
      • Support Options
      • Search for Answers
      • Chat Online
      • Call Us
      • View All
    • Online Forum
      • My Inbox
      • My Favorites
      • My Subscriptions
      • View All
    • My TechConnect
      • Chat History
      • Service Ticket History
      • Manage Your Favorite Answers
      • Field Service Request
      • View All
      • E-Learning Courses
      • Instructor-led Courses
      • Training Workstations
      • View All
    Support
    Contact Us HelpHelp Get Support LaunchpadTools and applications View All Tools
  • Company
    • Events Chevron RightChevron Right
    • News Chevron RightChevron Right
    • Careers Chevron RightChevron Right
    • PartnerNetwork Chevron RightChevron Right
    • About Us Chevron RightChevron Right
    • Featured Events
      • Automation Fair
      • Process Solutions User Group
      • Rockwell Automation On The Move
      • Rockwell Automation TechEd
      • PACK EXPO CONNECTS
      • View All
    • Webinars
      • Live
      • On-Demand
      • View All
      • Blogs
      • Case Studies
      • Automation Today
      • Podcasts
      • Press Releases
      • View All
      • View Jobs
      • Teams & People
      • Hackathon
      • Employee Video Spotlight
      • Authorized Distributors
      • Encompass Product Partners
      • Licensed Developers
      • OEM Partners
      • Strategic Alliance Partners
      • System Integrator Partners
      • PartnerNetwork Portal
      • View All
      • Our Brands
      • Our Community
      • Our History
      • Integrity & Sustainability
      • Investor Relations
      • View All
    Company
    ProductivityProductivity Investor Relations
  • Sales
  • Sales
  • View All Industries
  • View All
  • View All
  • View All
  • View All
  • Automotive & Tire
  • Cement
  • Chemical
  • Entertainment
  • Fibers & Textiles
  • Food & Beverage
  • Household & Personal Care
  • Infrastructure
  • Life Sciences
  • Marine
  • Metals
  • Mining
  • Oil & Gas
  • Power Generation
  • Print & Publishing
  • Pulp & Paper
  • Semiconductor
  • Water Wastewater
  • View All
  • The Connected Enterprise®
  • Consulting & Integration Services
  • Cybersecurity
  • Digital Transformation
  • Industrial Analytics
  • Industrial Automation & Control
  • Industrial Maintenance & Support
  • Industrial Networks
  • Lifecycle Services
  • Machine & Equipment Builders
  • MES Solutions
  • Process Solutions
  • Safety Solutions
  • View All
  • Circuit & Load Protection
  • Condition Monitoring
  • Connection Devices
  • Distributed Control Systems
  • Drives & Motors
  • Energy Monitoring
  • Human Machine Interface
  • Industrial Computers & Monitors
  • Input/Output Modules
  • Industrial Control Products
  • Lighting Control
  • Motion Control
  • Motor Control
  • Networks Security & Infrastructure
  • Packaged Solutions
  • Power Supplies
  • Programmable Controllers
  • Push Buttons & Signaling Devices
  • Relays & Timers
  • Safety Instrumented Systems
  • Safety Products
  • Sensors & Switches
  • Signal Interface
  • View All Hardware Products
  • View All
  • View All
  • Technical Documentation Center
  • Technical Specifications
  • Product Certifications
  • Product Drawings
  • Release Notes
  • Literature Library
  • View All
  • Instructor-led Courses
  • Training Workstations
  • View All
  • View All
  • Blogs
  • Case Studies
  • Automation Today
  • Podcasts
  • Press Releases
  • View All
  • View Jobs
  • View All
  • Authorized Distributors
  • Encompass Product Partners
  • Licensed Developers
  • OEM Partners
  • System Integrator Partners
  • PartnerNetwork Portal
  • View All
  • Our Brands
  • Our History
  • Investor Relations
  • View All
  • iTRAK Intelligent Track Systems
  • MagneMover Lite Intelligent Conveyor System
  • QuickStick Intelligent Conveyor System
  • View All
  • Dynamic Digital Twin Software
  • Studio 5000 Design Software
  • FactoryTalk Edge Gateway
  • FactoryTalk Batch
  • FactoryTalk Historian
  • FactoryTalk View - HMI Software
  • FactoryTalk Metrics
  • FactoryTalk Analytics for Devices
  • FactoryTalk AssetCentre
  • FactoryTalk Emonitor
  • FactoryTalk Network Manager
  • FactoryTalk TeamONE
  • Fiix CMMS
  • Augmented Reality
  • FactoryTalk Analytics
  • MES
  • ThingWorx IIoT Platform
  • 2D & 3D Drawings
  • Activations
  • Add-on Profiles
  • Application Code Libraries
  • Compatibility & Downloads
  • Drivers & Firmware
  • Electronic Datasheets
  • EPLAN Macros
  • Sample Code Library
  • Software Patches
  • View All
  • Control Systems Configuration Tools
  • Procurement Specifications
  • ProposalWorks Proposal Builder
  • Global Short-circuit Current Ratings Tool
  • Integrated Architecture Builder
  • View All
  • Migration & Modernization
  • Lifecycle Status
  • Product Replacement Lookup
  • View All
  • Support Options
  • Search for Answers
  • Chat Online
  • Call Us
  • View All
  • My Inbox
  • My Favorites
  • My Subscriptions
  • View All
  • Chat History
  • Service Ticket History
  • Manage Your Favorite Answers
  • Field Service Request
  • View All
  • My Training
  • View All
  • Automation Fair
  • Process Solutions User Group
  • Rockwell Automation On The Move
  • Rockwell Automation TechEd
  • PACK EXPO CONNECTS
  • View All
  • Live
  • On-Demand
  • View All
  • Students & New Grads
  • View All
  • Hackathon Use Case for Manufacturing Optimization
  • Hackathon Use Case for Sustainability
  • Hackathon Use Case for Visual System Modernization
  • Hackathon Use Case for Dynamic Filtering
  • View All
  • 24toCode Event Recap - Winter 2019
  • 24toCode Event Recap // IT Internal Hackathon
  • Meet the 2019 IT Summer Interns
  • 24toCode Promo Video
  • Harbor View Plaza Ribbon Cutting
  • Check Your Blind Spots Mobile Tour at Rockwell Automation
  • Mechanic & Tool Apprenticeship at Rockwell Automation
  • Working at Rockwell Automation in Karlsruhe
  • Summer Internships at Rockwell Automation
  • The Intrapreneurial Skills Accelerator at Rockwell Automation
  • Makers Wanted
  • #LifeatROK w Katowicach
  • IT Summer Internship Program
  • #LifeatROK with Diogo
  • View All
  • Cisco
  • Endress+Hauser
  • FANUC
  • Microsoft
  • Panduit
  • View All
  • Our Focused Giving
  • STEM Education
  • Lifelong Learning
  • View All
  • Sustainability Report
  • Our Commitment to Diversity, Equity and Inclusion
  • Environmental, Health, & Safety
  • Ethics & Compliance
  • Global Supply Chain & Sourcing
  • Product Environmental Compliance
  • Quality Management Systems
  • Trust & Security
  • Workforce of Tomorrow
  • View All
Case StudyRockwell Automation's case studies Case Studies DistributorDistributor How to Buy EventEvent Events
Blogs DistributorDistributor How to Buy EventEvent Events
Find Products by Our Brands:
Allen-Bradley FactoryTalk
Contact Us HelpHelp Get Support LaunchpadTools and applications View All Tools
ProductivityProductivity Investor Relations
  • Literature LibraryLiterature Library
    Literature Library

    Access technical and commercial publications for hardware and software products, applications, services and solutions.

    PCDCProduct Compatibility and Download Center
    Compatibility & Downloads

    Find downloads including firmware, release notes, associated software, drivers, tools and utilities.

    KnowledgebaseKnowledgebase Support Center
    Knowledgebase

    Browse the database of questions and answers on a variety of products and technologies.

    Product ConfiguratorProduct Configurator
    Product Configurator

    Configure and select products rapidly.

    Software SubscriptionsSoftware Subscriptions
    Software Subscriptions

    One stop shopping for software and subscription services.

    2D & 3D Drawings Bill of Materials CrossWorks Electronic Datasheets Motion Analyzer My Equipment My Training E-Learning Portal Product Lifecycle Status Product Registration Product Selection Toolbox Repairs Sample Code Library Software Activations View All
    Tools
    UserUser Sign In/Create an Account
  • User Account User
Tools
Literature LibraryLiterature Library
Literature Library
PCDCProduct Compatibility and Download Center
Compatibility & Downloads
KnowledgebaseKnowledgebase Support Center
Knowledgebase
Product ConfiguratorProduct Configurator
Product Configurator
Software SubscriptionsSoftware Subscriptions
Software Subscriptions
2D & 3D Drawings Bill of Materials CrossWorks Electronic Datasheets Motion Analyzer My Equipment My Training E-Learning Portal Product Lifecycle Status Product Registration Product Selection Toolbox Repairs Sample Code Library Software Activations View All
Case Study
Recent ActivityRecent Activity

Leading Medical Device Manufacturer Goes Paperless

Share This:

LinkedInLinkedIn
TwitterTwitter
FacebookFacebook
PrintPrint
EmailEmail
Main Image

Solutions

  • Manufacturing Intelligence - FactoryTalk® software gathers data from control system to automate FDA reporting and enable process improvements
  • PartnerNetwork Solution Provider - ACC provided system design, configuration, implementation and project management paired with industry expertise

Results

  • eDHR generated with significantly less manual intervention than paper-based records
  • Exception-based reporting reduces time for product release
  • Implemented end-to-end tracking and tracing system to improve risk management and quality control
  • Production data automatically pulled into paperless reporting system for compliance
  • Increased productivity 20 percent over previous system Improved operator productivity with automated alerts

Challenge

A leading medical manufacturer serving the growing demographic of aging baby boomers needed to rapidly expand production capacity to keep up with growing demand. With limited space in its facility to add new lines, the company needed to focus on improving cycle time and yield. To improve cycle times, company leaders wanted to gather more data about its process to establish ideal operating parameters. To address yield while operating under tight regulations and reporting requirements, the company needed to reduce or eliminate losses and shipment delays caused by reporting or quality issues. Upgrades were made to production control and reporting systems to add capacity, improve quality and simplify regulatory reporting.

The device manufacturer worked with Rockwell Automation Solution Partner Automated Control Concepts, Inc. (ACC) to develop a manufacturing intelligence strategy that eases the collection of data necessary to generate the FDA-required Device History Record for each lot and unit they produce. In addition, electronically available data has helped the customer gain visibility and traceability, driving process improvements. As part of this approach, ACC designed an information system based on the FactoryTalk software suite from Rockwell Automation and ACC's own proprietary software, processRecords®.

Solution

The FactoryTalk suite provides a standard platform for security and communications – with each application gathering data directly from the manufacturing and testing control system. The system can be easily expanded to incorporate data from additional machines, lines or areas of production, as necessary.

Specifically, FactoryTalk Historian software collects and archives historical and real-time manufacturing and testing data from third-party applications. To visualize the runtime data, ACC deployed FactoryTalk View software. Built-in write and security capabilities in FactoryTalk View software allowed the company to gather signatures verifying metrics gathered by the control system needed for compliance reasons. Authorized users simply provide an electronic signature directly through their control screen.

Production data gathered by the FactoryTalk applications is automatically gathered by the processRecords software and combined with manual entries required for FDA compliance. The software then automatically and securely compiles an electronic device history record for each medical device that tracks development.

The system also produces reports used throughout the day by the manufacturing and testing team to compare lot metrics to previous results to ensure quality. FactoryTalk VantagePoint EMI software aggregates information from all other FactoryTalk and processRecords applications and produces real-time dashboards and reports with unique situational and historical context for different users.

The analytics provided by the system have empowered the production team to bring process improvement recommendations to business management. Because their guidance is rooted in real metrics, production staff has taken a greater role in directing research and development (R&D) activities. For example, input from the production team has already caused the R&D team to hold-off on purchasing a new furnace system while they narrow down optimal furnace requirements with the manufacturing intelligence data and analysis provided by the new system.

Results

Since the initial installation, the company has extended the manufacturing intelligence strategy from production to its extensive testing process. It's also worked with ACC to install large LCD screens though out the plant floor to help managers clearly see the status of operations across the plant, where physical visibility is limited. Alarms and inconsistencies are clear and immediately noticeable, so if action is required, managers can quickly pull up the same screen through their local human-machine interface (HMI) to enact a change or optimize a process.

With actions taken based on manufacturing intelligence, the device manufacturer has tightened up the heat and run-time tolerances in its furnaces. Use of the new system has helped operators attain five percent increase in equipment efficiency through better equipment utilization. In addition, enforced workflow provided by the software's proactive alerts has increased productivity by 20 percent, while plant floor staffing has remained the same.

Published July 2, 2012

Subscribe

Subscribe to Rockwell Automation and receive the latest news, thought leadership and information directly to your inbox.

Subscribe

Recommended For You

Loading
  • Technical Question
  • Chat Technical Support
  • Phone Support
  • Contact Sales
  • General Questions
  1. Chevron LeftChevron Left Indonesia Chevron RightChevron Right
  2. Chevron LeftChevron Left Company Chevron RightChevron Right
  3. Chevron LeftChevron Left News Chevron RightChevron Right
  4. Chevron LeftChevron Left Case Studies Chevron RightChevron Right
Discover
  • The Connected Enterprise®
  • Create Your Account
  • Case Studies
  • Events
Information for...
  • Distributors
  • OEM
  • System Integrators
  • Encompass Partners
  • Investors
  • Career Seekers
Contact Us
  • General Questions
  • Technical Questions
  • Local Sales & Service
  • Pricing & Availability
  • Report Ethical Concerns
  • Customer Experience Survey
Site Information
  • Legal
  • Privacy Policy
  • Cookie Preferences
  • Terms of Use
  • Trademarks
Change Country Site SelectionChange RockwellAutomation.com site selection to a different country, region or language Change Country
Indonesia/English

Keep Updated With Us

Sign up to receive our latest headlines for free.

Stay Informed Now
Follow Us
BlogRockwell Automation's Blog
Copyright ©2021 Rockwell Automation, Inc.
Indonesia