• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    20 Years: A Discussion on the Past & Future of Medical Product Outsourcing

    A Combined Effort for Drug Delivery & Combo Product Technology

    Examining Medical Packaging & Sterilization on Multiple Fronts

    Medical Molding Modernized

    Computer Concepts for Medical Device Design
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Teleflex’s Wattson temporary pacing guidewire FDA cleared

    PDC Partners with David Schnur Associates to Provide Manufacturing Solutions

    Olympus Releases Next-Gen ESG-410 Electrosurgical Generator

    NICO Corporation Touts Positive ENRICH Trial Results

    Study Reveals Graphene-Based Biosensors' Potential in Detecting Critical Biomarker
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    20 Years: A Discussion on the Past & Future of Medical Product Outsourcing

    A Combined Effort for Drug Delivery & Combo Product Technology

    Examining Medical Packaging & Sterilization on Multiple Fronts

    Medical Molding Modernized

    Computer Concepts for Medical Device Design
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Elizabeth Holmes’ Pre-Prison Public Persona

    Trending in Healthcare Dealmaking: Creativity, Diversification, and Distress

    How Human Factors Engineering Can Contribute to Medical Device Packaging

    How Companies Can Create a Unique Selling Proposition

    Updating Medical Device Software in the Field
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Halkey-Roberts Corporation

    Providence Enterprise USA Inc.

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How the CHIPS Act and R&D Tax Credits Will Shape the Medtech Manufacturing Landscape

    Solving the Skills Gap Stalling the March of UK Life Sciences

    5 Ways to Reduce Nearshoring & Reshoring Costs Using Automation

    The Future of Hearing Aids: xMEMS Develops All-Silicon, Solid-State Micro Speaker

    Navigating Chinese Regulatory Requirements for Medical Device Localization
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    Halkey-Roberts Corporation

    Providence Enterprise USA Inc.

    Cirtec Medical
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    Adopting a Data-Driven Quality Model

    Employing a data-driven quality model helps you apply quality processes more holistically throughout the organization.

    Adopting a Data-Driven Quality Model
    David Jensen, Staff Writer, MasterControl04.09.21
    On several occasions, Acting Commissioner of the U.S. Food and Drug Administration (FDA) Janet Woodcock has called attention to the importance of quality in product manufacturing. Given the high rate of drug shortages, she stresses that quality goes beyond simply meeting the FDA’s current good manufacturing practice (CGMP) requirements. Quality in manufacturing is the ability to reliably produce products in sufficient quantities to ensure that supply meets demand.
     
    “Analysis of recent drug shortages indicates the need for rewarding more investment in quality. A team of FDA economists examined a sample of 163 drugs that first went into shortage between calendar years 2013 and 2017. They found that of the 163 drugs in shortage, 62 percent went into shortage after supply disruptions that were associated with manufacturing or product quality problems,” said Woodcock.
     
    Data’s Pivotal Role in Quality
    Life sciences companies have long generated vast amounts of data as a byproduct of their processes for developing and manufacturing products. Quality is one area of the business that is particularly dependent on data. Comparatively, quality gathers and uses more data than other business units in an organization.
     
    As long as companies follow the regulatory guidelines for data management and have the required documentation in place, they can achieve regulatory compliance. However, quality processes that involve compiling and storing data on paper documents require more time and effort than is necessary. In fact, it fosters more of a reactive rather than proactive approach to quality. Quality managers often need to spend more time double checking documents and following up with stakeholders to ensure records are complete and accurate. The challenges associated with this approach include:
     
    • Data is gathered in multiple formats and stored in various repositories, making it difficult to disseminate to those who need it.
    • Stakeholders don’t have important data until it comes to them.
    • Data sets are at risk of being incomplete or containing errors, which can adversely impact reports and submissions.
    • Data is insufficient for effectively investigating and resolving procedure and product deviations.
     
    Quality Data Is Essential for Producing Quality Products
    Your quality efforts and objectives should be driven by the needs of your customers. Based on these needs, you will typically create a product specification that indicates a precise target for each of the product’s critical characteristics—with minimal variation around the target for quality. But how can you ensure you maintain that level of quality throughout the product’s life cycle?
     
    Advanced technologies are making data more abundant and more focus-area specific. Incorporating the following technologies into your quality processes gives your company a tactical advantage:
     
    • Internet of things (IoT): An ecosystem of web-enabled smart devices that collect, send and act on data they obtain with a high level of accuracy.
    • Big data: The ability to quickly gather and aggregate large amounts and various types of data in real time.
    • Predictive analytics: The use of new and historical data to forecast industry activities, behaviors and trends. Using predictive analytics allows stakeholders to see around corners and make more confident decisions.
     
    According to a Garter survey on internet of things (IoT) technology, life sciences companies are implementing digitized technologies specifically to gather more data and gain more value from it. For example, using predictive analytics, life sciences companies can quickly identify trends, spot unforeseen or overlooked risks and mitigate deviations before they cause delays or result in a product recall.
     
    Employing a data-driven quality model helps you apply quality processes more holistically throughout the organization, as quality needs to be more of a collective effort, not just the responsibility of one department. This approach to quality will become a key business strategy as you strive to boost production capabilities, reduce throughput times and pursue continuous improvement. Other benefits include:
     
    • Quality and manufacturing can be better aligned and more transparent.
    • Staff can focus on business-critical tasks, rather than reacting to events after they occur.
    • Overall performance and right-first-time metrics can improve significantly.
     
    A survey report from Accenture Life Sciences explains how the life sciences industry is at an inflection point. Companies throughout the industry now recognize that to remain competitive they need to make better use of all their data assets. It further cites that to be a leader in this new data-driven world, life sciences companies must fundamentally transform how they create, manage and effectively use all their data.
     
    Organizations that adopt a data-driven, platform-enabled quality model will augment their capacity to yield real-time quality intelligence and predictive insights. When equipped with the ability to collect and share data within a common platform, every function within an organization can have an appreciable impact on product quality.
     

    David Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials, and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing, and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.
     
    Related Searches
    • Software & IT
    Related Knowledge Center
    • Software & IT
    Suggested For You
    Johari Digital Healthcare Ltd. Johari Digital Healthcare Ltd.
    Web Industries Inc. Web Industries Inc.
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    DDL Inc. DDL Inc.
    sfm medical devices GmbH sfm medical devices GmbH
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    UPDATE: Medtronic to Replace Recalled MiniMed Insulin Pumps UPDATE: Medtronic to Replace Recalled MiniMed Insulin Pumps
    Molli Surgical Molli Surgical's Breast Tumor Marker
    Glooko’s Remote Patient Monitoring for Diabetics Glooko’s Remote Patient Monitoring for Diabetics
    Valencell’s Wearable Biomedical Sensors Valencell’s Wearable Biomedical Sensors
    Global Peripheral Intravenous Catheter Market to Reach $7.3B by 2027 Global Peripheral Intravenous Catheter Market to Reach $7.3B by 2027
    Knobbe Martens Talks Trade Secrets Knobbe Martens Talks Trade Secrets
    Implicity’s Cardiac Device Remote Monitoring Implicity’s Cardiac Device Remote Monitoring
    PixCell PixCell's Rapid Blood Test Diagnostics

    Related Buyers Guide Companies

    • Johari Digital Healthcare Ltd.

      ...
      Kamal Kumawat, Marketing Manager 12.06.22

    • Web Industries Inc.

      ...
      Blake Phillips, Marketing Specialst 11.18.22

    • JK Medirise-Disposable Medical Device Company

      ...
      Ketan Munjani, Marketing Manager 11.17.22


    • DDL Inc.

      DDL Inc.

      DDL has been in medical device package, product and material testing industry for almost 20 years. We strive to offer the most effective business practices while employing a staff of technical experts.
      Chris Murphy, Marketing Manager 11.11.22

    • sfm medical devices GmbH

      ...
      Albert Busch, Head of Marketing 11.11.22

    Loading, Please Wait..

    Trending
    • Olympus To Establish Digital Excellence Centers
    • A New Approach To Post-Market Surveillance
    • Philips Names New Supervisory Board Chairman
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Labcorp's Clinical Development Spinoff To Be Called Fortrea
    Breaking News
    • Teleflex’s Wattson temporary pacing guidewire FDA cleared
    • PDC Partners with David Schnur Associates to Provide Manufacturing Solutions
    • Olympus Releases Next-Gen ESG-410 Electrosurgical Generator
    • NICO Corporation Touts Positive ENRICH Trial Results
    • Study Reveals Graphene-Based Biosensors' Potential in Detecting Critical Biomarker
    View Breaking News >
    CURRENT ISSUE

    June 2023

    • 20 Years: A Discussion on the Past & Future of Medical Product Outsourcing
    • A Combined Effort for Drug Delivery & Combo Product Technology
    • Examining Medical Packaging & Sterilization on Multiple Fronts
    • Medical Molding Modernized
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Blue Diamond, Brightseed Partner To Discover New Almond Bioactives
    GOED Publishes Report on EPA and DHA’s Impact on Brain Health
    Alkemist Labs Creates Validated Method for Plant and Fungi-Based Psychedelics
    Coatings World

    Latest Breaking News From Coatings World

    Sandrine Garnier Joins ChemQuest as a Director
    Greenbuild Announces 2023 Keynote Speaker
    PPG’s New Paint for a New Start Initiative to Beautify Schools Worldwide with Colorful Makeovers
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    PDC Partners with David Schnur Associates to Provide Manufacturing Solutions
    Olympus Releases Next-Gen ESG-410 Electrosurgical Generator
    NICO Corporation Touts Positive ENRICH Trial Results
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Qosina, Carolina Components Partner to Market Bioprocess Components
    Astellas, KateTx Enter Exclusive License Agreement to Develop KT430
    Telix Opens $21.2M European Radiopharmaceutical Production Facility
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Boots CFO Michael Snape Resigns
    Beiersdorf Shares Progress of Its Sustainability Agenda
    Estée Lauder Announces Second Edition of Beauty&You Brand Incubator Program
    Happi

    Latest Breaking News From Happi

    TerraCycle and Wrinkles Schminkles Partner in new Recycling Program
    FDA Sends Warning Letter To Maker of Mr. Lulu Sunscreen Drops
    Enhanced Sustainable Nivea Sun and Lip Care Products
    Ink World

    Latest Breaking News From Ink World

    SICPA Inaugurates Its unlimitrust Campus
    Siegwerk’s Center of Excellence in France Receives Facelift
    Epson announces MakeTheSwitch Campaign
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Gallus to celebrate 100 years, opening new Gallus Experience Center
    Mark Andy holds successful Low Migration Workshop
    Ryback & Ryback Consulting launches Machinery division
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Terra Baby Diapers, Wipes Launch in U.S. and Canada
    The Honest Company to Exit Europe, Asia
    TechnoPlants to Exhibit at ITMA
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Osso VR Launches Virtual Reality Training Program
    Catalyst OrthoScience Names Mark Quick as CFO
    European Regulators Approve Amber Implants' VCFix Spinal System Study
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Sensormatic Unveils Sensormatic Synergy Media Display
    ams OSRAM Receives the German Innovation Award
    ASSA ABLOY Receives Clearance from Mexico for HHI Acquisition

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login