This presentation presents key findings from LNS Research's yearlong benchmark study of over 500 global quality executives. It details how market leaders are leveraging EQMS software, and makes recommendations for executives looking to learn more or invest in this space.
Understanding Enterprise Quality Management Systems (EQMS)Sparta Systems
The quality software landscape has progressed to become enterprise-level solutions, whose integrated systems enable organizations to implement automated quality processes tailored to align with each of their specific products and business practices. This presentation from Sparta Systems explains the concept of Enterprise Quality Management Systems (EQMS).
ManageArtworks is a Cloud based Packaging Artwork Management and Labeling Software which helps Pharma, Food and Cosmetic companies gain a competitive edge.
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
Understanding Enterprise Quality Management Systems (EQMS)Sparta Systems
The quality software landscape has progressed to become enterprise-level solutions, whose integrated systems enable organizations to implement automated quality processes tailored to align with each of their specific products and business practices. This presentation from Sparta Systems explains the concept of Enterprise Quality Management Systems (EQMS).
ManageArtworks is a Cloud based Packaging Artwork Management and Labeling Software which helps Pharma, Food and Cosmetic companies gain a competitive edge.
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
Agile Computer System Validation of software productsWolfgang Kuchinke
Personalized medicine seems to be a potential solution to the known challenges facing clinical research and drug development. To be employed in clinical research, software tools must undergo a process called Computer System Validation (CSV) for compliance with legal requirements and Good Clinical Practice (GCP). Four academic developer groups of the EU project p-medicine were surveyed to evaluate the readiness of their developed software products to be used for clinical research. The analysis of the survey showed that considerable gaps exist in tool maintenance, quality management and compliance documentation. Because all developer groups use agile development methods, recommendations for agile quality assurance were developed as well as for using agile methods to establish “compliance by design”. We show how agile validation can be established by small modifications of sprint processes.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
Good Manufacturing Practice, or GMP, is a set of practices and systems that are aimed at making sure that pharmaceutical products are manufactured in conformance with set requirements and standards. The aim of GMP also referred to sometimes as cGMP or Current Good Manufacturing Practice, is to ensure that there is control and consistency in the pharmaceutical products, so that the processes used for controlling quality and consistency of the product can be traced back in the event of a problem.
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
Presentation by NEPAD Agency on the African Medicines Regulatory Harmonisation made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
Pharmaceutical Company Facility PresentationPalash Das
This presentation is dedicated to all pharmaceutical organization. this can be use as a standard template for presenting your organization during audit. The concept is designed based on the sterile pharmaceutical facility.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Pharmaceutical Quality Management System describes the framework of planning, organizing, controlling and monitoring of activities throughout product life cycle. This presentation briefly describes the fabric of QMS which provides the foundation of quality products.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
FDA Regulations and Medical Device Pathways to Market | Kevin Daly | Lunch & ...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Building a Business Case for Quality Management TransformationVeeva Systems
Watch the video here: bit.ly/qualitytransformation_ondemand
Transforming quality management to make it easier to comply with regulations and enable faster and more informed decisions is disruptive – impacting people, processes, and systems. With a business case demonstrating anticipated benefits and savings, teams can justify the costs for change, gain stakeholder support, and ensure alignment.
Many organizations have a fragmented system landscape and outdated or manual quality processes. Leading companies are migrating to modern, cloud systems to enable continuous improvement and accelerate transformation initiatives. They are also re-evaluating processes – adopting current best practices and optimizing investments in new technology.
By watching this on demand webinar with quality experts from PriceWaterhouseCoopers (PwC) and Veeva Systems. You will learn how to build a business case to support quality management transformations including:
• Getting a framework for developing business cases
• How to move from a cost to value structure leveraging Quality 4.0
• Recommendations on calculating TCO with key considerations
• Guidance on navigating complex organizations to gain support
Who Will Benefit:
• VP/Director of Quality and Compliance (QA or QC), Quality Systems
• VP/Director of Information Technology, Quality Management Systems, Quality Systems
• VP/Director of Manufacturing Operations/ Quality Operations/ Supply Chain
• Document/Records Managers/ Directors
• Director, Regulatory Operations/ Regulatory Affairs (CMC – Chemistry, Manufacturing, and Control)
• IT System Administrators
• Quality Training Coordinator
Meet Your Presenters:
Jan Paul (JP) Zonnenberg
Partner, Pharmaceutical and Life Sciences Companies, PwC
As a Partner and co-Lead for PwC’s Quality Management Systems Practice, JP’s concentration is in global operations and specifically in quality systems and QMS information technology within the Life Sciences Business Group. With over 28 years’ experience in pharmaceuticals, biotechnology, and medical devices & diagnostics, JP helps leading companies proactively think about developing next generation quality systems to ensure both effective and efficient organizations.
Mike Jovanis
VP Vault Quality, Veeva Systems
As Vice President of the Vault Quality product suite, Mike is responsible for product strategy, customer engagement, and business development. Previously, he served as vice president of product management and strategy for Sparta Systems, where he was instrumental in the company's rapid growth, driving product development, vertical market strategy, and strategic partner alliances. Educated at Rutgers, he holds a bachelor’s degree in marketing and an MBA in strategy and global business.
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
Agile Computer System Validation of software productsWolfgang Kuchinke
Personalized medicine seems to be a potential solution to the known challenges facing clinical research and drug development. To be employed in clinical research, software tools must undergo a process called Computer System Validation (CSV) for compliance with legal requirements and Good Clinical Practice (GCP). Four academic developer groups of the EU project p-medicine were surveyed to evaluate the readiness of their developed software products to be used for clinical research. The analysis of the survey showed that considerable gaps exist in tool maintenance, quality management and compliance documentation. Because all developer groups use agile development methods, recommendations for agile quality assurance were developed as well as for using agile methods to establish “compliance by design”. We show how agile validation can be established by small modifications of sprint processes.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
Good Manufacturing Practice, or GMP, is a set of practices and systems that are aimed at making sure that pharmaceutical products are manufactured in conformance with set requirements and standards. The aim of GMP also referred to sometimes as cGMP or Current Good Manufacturing Practice, is to ensure that there is control and consistency in the pharmaceutical products, so that the processes used for controlling quality and consistency of the product can be traced back in the event of a problem.
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
Presentation by NEPAD Agency on the African Medicines Regulatory Harmonisation made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
Pharmaceutical Company Facility PresentationPalash Das
This presentation is dedicated to all pharmaceutical organization. this can be use as a standard template for presenting your organization during audit. The concept is designed based on the sterile pharmaceutical facility.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Pharmaceutical Quality Management System describes the framework of planning, organizing, controlling and monitoring of activities throughout product life cycle. This presentation briefly describes the fabric of QMS which provides the foundation of quality products.
Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
FDA Regulations and Medical Device Pathways to Market | Kevin Daly | Lunch & ...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Building a Business Case for Quality Management TransformationVeeva Systems
Watch the video here: bit.ly/qualitytransformation_ondemand
Transforming quality management to make it easier to comply with regulations and enable faster and more informed decisions is disruptive – impacting people, processes, and systems. With a business case demonstrating anticipated benefits and savings, teams can justify the costs for change, gain stakeholder support, and ensure alignment.
Many organizations have a fragmented system landscape and outdated or manual quality processes. Leading companies are migrating to modern, cloud systems to enable continuous improvement and accelerate transformation initiatives. They are also re-evaluating processes – adopting current best practices and optimizing investments in new technology.
By watching this on demand webinar with quality experts from PriceWaterhouseCoopers (PwC) and Veeva Systems. You will learn how to build a business case to support quality management transformations including:
• Getting a framework for developing business cases
• How to move from a cost to value structure leveraging Quality 4.0
• Recommendations on calculating TCO with key considerations
• Guidance on navigating complex organizations to gain support
Who Will Benefit:
• VP/Director of Quality and Compliance (QA or QC), Quality Systems
• VP/Director of Information Technology, Quality Management Systems, Quality Systems
• VP/Director of Manufacturing Operations/ Quality Operations/ Supply Chain
• Document/Records Managers/ Directors
• Director, Regulatory Operations/ Regulatory Affairs (CMC – Chemistry, Manufacturing, and Control)
• IT System Administrators
• Quality Training Coordinator
Meet Your Presenters:
Jan Paul (JP) Zonnenberg
Partner, Pharmaceutical and Life Sciences Companies, PwC
As a Partner and co-Lead for PwC’s Quality Management Systems Practice, JP’s concentration is in global operations and specifically in quality systems and QMS information technology within the Life Sciences Business Group. With over 28 years’ experience in pharmaceuticals, biotechnology, and medical devices & diagnostics, JP helps leading companies proactively think about developing next generation quality systems to ensure both effective and efficient organizations.
Mike Jovanis
VP Vault Quality, Veeva Systems
As Vice President of the Vault Quality product suite, Mike is responsible for product strategy, customer engagement, and business development. Previously, he served as vice president of product management and strategy for Sparta Systems, where he was instrumental in the company's rapid growth, driving product development, vertical market strategy, and strategic partner alliances. Educated at Rutgers, he holds a bachelor’s degree in marketing and an MBA in strategy and global business.
• How to transform a diverse QMS landscape into a state of the art global Quality System through relationship building and trust
• Building Management support — top down
• Clear vision and persistency will prevail
• Creating value at every step of the way
• Delivering compliance, effectiveness and efficiency for highest patient safety
Quality Management software helps organizations maintain uniformity and consistency in their products and services. It focuses on end-to-end processes, right from the quality of products and services to the activities and means to achieving it and consistently managing it. One such tool is - BM QualityMaster. It allows businesses to improve quality, achieve compliance, decrease risk, and reduce complaints by streamlining their quality management. Check out the PPT to know further-
Software Testing Process, Testing Automation and Software Testing TrendsKMS Technology
This is the slide deck that KMS Technology's experts shared useful information about latest and greatest achievements of software testing field with lecturers of HCMC University of Industry.
How to Drive Engagement with Enterprise Compliance SoftwareQualsys Ltd
Rob Gibson is an experienced IT Systems Manager who has developed his career at facilities management and food service company Sodexo. Over the past four years, Rob has been instrumental in rolling out EQMS - an electronic quality and compliance management system. Sodexo use EQMS to manage document control, audits, incident logging and training records for many of their heavily-regulated sites. Rob has introduced and managed a number of initiatives to raise awareness of the system and engage its users. Rob and his team are now on an exciting journey to roll out EQMS worldwide. As Sodexo is one of the largest employers in the world, this is not without its challenges! In this presentation, Rob shares his journey, tips and advice for rolling out a global quality and compliance management software solution.
Productivity & Total Quality ManagementVaibhav Bhatt
Productivity and Total Quality Management Importance For An Organisation And How Can They Develop And Overall Efficiency Through Proper Quality Management Techniques
Essentials of Automations: Optimizing FME Workflows with ParametersSafe Software
Are you looking to streamline your workflows and boost your projects’ efficiency? Do you find yourself searching for ways to add flexibility and control over your FME workflows? If so, you’re in the right place.
Join us for an insightful dive into the world of FME parameters, a critical element in optimizing workflow efficiency. This webinar marks the beginning of our three-part “Essentials of Automation” series. This first webinar is designed to equip you with the knowledge and skills to utilize parameters effectively: enhancing the flexibility, maintainability, and user control of your FME projects.
Here’s what you’ll gain:
- Essentials of FME Parameters: Understand the pivotal role of parameters, including Reader/Writer, Transformer, User, and FME Flow categories. Discover how they are the key to unlocking automation and optimization within your workflows.
- Practical Applications in FME Form: Delve into key user parameter types including choice, connections, and file URLs. Allow users to control how a workflow runs, making your workflows more reusable. Learn to import values and deliver the best user experience for your workflows while enhancing accuracy.
- Optimization Strategies in FME Flow: Explore the creation and strategic deployment of parameters in FME Flow, including the use of deployment and geometry parameters, to maximize workflow efficiency.
- Pro Tips for Success: Gain insights on parameterizing connections and leveraging new features like Conditional Visibility for clarity and simplicity.
We’ll wrap up with a glimpse into future webinars, followed by a Q&A session to address your specific questions surrounding this topic.
Don’t miss this opportunity to elevate your FME expertise and drive your projects to new heights of efficiency.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Key Trends Shaping the Future of Infrastructure.pdfCheryl Hung
Keynote at DIGIT West Expo, Glasgow on 29 May 2024.
Cheryl Hung, ochery.com
Sr Director, Infrastructure Ecosystem, Arm.
The key trends across hardware, cloud and open-source; exploring how these areas are likely to mature and develop over the short and long-term, and then considering how organisations can position themselves to adapt and thrive.
Builder.ai Founder Sachin Dev Duggal's Strategic Approach to Create an Innova...Ramesh Iyer
In today's fast-changing business world, Companies that adapt and embrace new ideas often need help to keep up with the competition. However, fostering a culture of innovation takes much work. It takes vision, leadership and willingness to take risks in the right proportion. Sachin Dev Duggal, co-founder of Builder.ai, has perfected the art of this balance, creating a company culture where creativity and growth are nurtured at each stage.
Generating a custom Ruby SDK for your web service or Rails API using Smithyg2nightmarescribd
Have you ever wanted a Ruby client API to communicate with your web service? Smithy is a protocol-agnostic language for defining services and SDKs. Smithy Ruby is an implementation of Smithy that generates a Ruby SDK using a Smithy model. In this talk, we will explore Smithy and Smithy Ruby to learn how to generate custom feature-rich SDKs that can communicate with any web service, such as a Rails JSON API.
Dev Dives: Train smarter, not harder – active learning and UiPath LLMs for do...UiPathCommunity
💥 Speed, accuracy, and scaling – discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Mining™:
See how to accelerate model training and optimize model performance with active learning
Learn about the latest enhancements to out-of-the-box document processing – with little to no training required
Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
This is a hands-on session specifically designed for automation developers and AI enthusiasts seeking to enhance their knowledge in leveraging the latest intelligent document processing capabilities offered by UiPath.
Speakers:
👨🏫 Andras Palfi, Senior Product Manager, UiPath
👩🏫 Lenka Dulovicova, Product Program Manager, UiPath
Connector Corner: Automate dynamic content and events by pushing a buttonDianaGray10
Here is something new! In our next Connector Corner webinar, we will demonstrate how you can use a single workflow to:
Create a campaign using Mailchimp with merge tags/fields
Send an interactive Slack channel message (using buttons)
Have the message received by managers and peers along with a test email for review
But there’s more:
In a second workflow supporting the same use case, you’ll see:
Your campaign sent to target colleagues for approval
If the “Approve” button is clicked, a Jira/Zendesk ticket is created for the marketing design team
But—if the “Reject” button is pushed, colleagues will be alerted via Slack message
Join us to learn more about this new, human-in-the-loop capability, brought to you by Integration Service connectors.
And...
Speakers:
Akshay Agnihotri, Product Manager
Charlie Greenberg, Host
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Accelerate your Kubernetes clusters with Varnish CachingThijs Feryn
A presentation about the usage and availability of Varnish on Kubernetes. This talk explores the capabilities of Varnish caching and shows how to use the Varnish Helm chart to deploy it to Kubernetes.
This presentation was delivered at K8SUG Singapore. See https://feryn.eu/presentations/accelerate-your-kubernetes-clusters-with-varnish-caching-k8sug-singapore-28-2024 for more details.
Elevating Tactical DDD Patterns Through Object CalisthenicsDorra BARTAGUIZ
After immersing yourself in the blue book and its red counterpart, attending DDD-focused conferences, and applying tactical patterns, you're left with a crucial question: How do I ensure my design is effective? Tactical patterns within Domain-Driven Design (DDD) serve as guiding principles for creating clear and manageable domain models. However, achieving success with these patterns requires additional guidance. Interestingly, we've observed that a set of constraints initially designed for training purposes remarkably aligns with effective pattern implementation, offering a more ‘mechanical’ approach. Let's explore together how Object Calisthenics can elevate the design of your tactical DDD patterns, offering concrete help for those venturing into DDD for the first time!
Smart TV Buyer Insights Survey 2024 by 91mobiles.pdf91mobiles
91mobiles recently conducted a Smart TV Buyer Insights Survey in which we asked over 3,000 respondents about the TV they own, aspects they look at on a new TV, and their TV buying preferences.
Epistemic Interaction - tuning interfaces to provide information for AI supportAlan Dix
Paper presented at SYNERGY workshop at AVI 2024, Genoa, Italy. 3rd June 2024
https://alandix.com/academic/papers/synergy2024-epistemic/
As machine learning integrates deeper into human-computer interactions, the concept of epistemic interaction emerges, aiming to refine these interactions to enhance system adaptability. This approach encourages minor, intentional adjustments in user behaviour to enrich the data available for system learning. This paper introduces epistemic interaction within the context of human-system communication, illustrating how deliberate interaction design can improve system understanding and adaptation. Through concrete examples, we demonstrate the potential of epistemic interaction to significantly advance human-computer interaction by leveraging intuitive human communication strategies to inform system design and functionality, offering a novel pathway for enriching user-system engagements.
3. Agenda
•About LNS Research
•Why Quality Matters
•Benchmark Data
•Strategic Objectives
•Our Biggest Challenges
•Building a Model of Operational Excellence
•EQMS Best Practices
•Recommendations for Success
#GlobalEQMS
4. Understanding LNS
LNS is research and advisory firm that helps
clients innovate and achieve operational
excellence.
We deliver the market intelligence and
thought leadership needed to capture the
value of technology through:
Experienced analysts
Primary research
Deep industry contacts
Interactive data visualizations
#GlobalEQMS
5. Global Quality Advisory Council
Starbucks - VP of Global Quality and Regulatory Affairs
Onyx Pharmaceutical - VP of Global Quality
Whirlpool - Director of Quality
Lindt Chocolate – VP R&D and Quality
Oriflame - Corporate Quality Lead
Champion Technology - VP Quality and EH&S
Gurwitch Products - VP Research and Quality
Newell Rubbermaid - Director of Quality
Hygia Health Service - VP of Operations
Discount Tire - VP of Quality
Daikin McQuay - Director, Corporate Quality
Bio-Rad Laboratories – Director of Quality Assurance
Owens-Illinios – VP of Global Quality
Harley Davidson – Director Corporate Quality
Alcoa – Director Corporate Quality
#GlobalEQMS
9. The Changing Customer and Speed of News
Changing preferences regarding where news is
received, where research is conducted, and how
opinions are formed
LA Times, Boston Globe:
For Sale
Google Reader:
Shuts Down
Facebook and LinkedIn:
News Feeds Transformed
#GlobalEQMS
10. The Changing Customer
Social Proof is the New Paradigm
•People are starting the buying process online
•Everything is ranked, rated, and reviewed
•Buyers are interested in what others are interested in
•They trust other people in their network
•Good and poor quality are hard to hide
Breaking News: Company X Recalls
1,000,000 Cars in U.S.
4/4/13
Boston, MA – After several incidents, Company X has
decided to recall model 302z from its 2010 fleet. Owners
are asked to return their automobiles to dealers for faulty
#GlobalEQMS
11. Global Scale for Products and Operations
275 subsidiary companies, in 60
countries with 146 manufacturing sites
250+ brands, 26 Billion Dollar brands,
100+ manufacturing sites, consumers in
180 countries
50+ manufacturing sites in 25+ countries
with almost 10,000,000 units sold across
70 models
#GlobalEQMS
12. Top 5 Financial Objectives
•Growing revenue is top for the majority of all companies
#GlobalEQMS
13. Top 5 Operational Objectives
•Improving manufacturing efficiency is top but not well
aligned to financial goals
#GlobalEQMS
14. Top 5 Quality Management Objectives
•Quality goals are synched with operations but not
necessarily financial goals
#GlobalEQMS
15. Top 5 Quality Challenges
•The top challenges are around Culture, metrics, and
systems - all important elements of Operational Excellence
#GlobalEQMS
17. Why Enterprise Quality Management Software
•Disparate systems and business process
•Lack of visibility into performance, compliance, and
risk
•Nearly impossible to collaborate across
departments, trading partners, or the supply chain.
•Quality and non-conformance data, as well as best
practices, are not shared across the organization
•Connecting Risk and Compliance as part of a
quality platform
#GlobalEQMS
18. Current System Landscape
•ERP – Financial data, inventory data, production routings,
recipe management
•BI – Reporting, Analytics, Visibility
•CRM – Customer complaints, trade promotions
•PLM – Labeling management, packaging management,
quality specifications, sampling plans
•LIMS – Measurements and testing of Fats, solids, bacteria
counts, etc.
•MOM – In line and at line testing, statistical process control,
manufacturing non-conformances
•SCM – Supplier risk scorecards, delivery scheduling,
inspection
•EHS – Carbon management, energy management,
reporting
#GlobalEQMS
23. Adoption of EQMS of Functionality
•Because, Life Sciences companies view
functionality as disparate systems: Doc Control,
CAPA, Compliance, Risk and more
#GlobalEQMS
24. Interconnecting Quality Processes
Identification Investigation Escalation Correction Prevention Efficacy
Assess Quantify Prioritize Mitigate
Establish Criteria Assessment Reporting Communication Follow up
Design Monitor Control
CAPA
Process
Risk
Management
Audit
Management
Good
Manufacturing
Practices
#GlobalEQMS
26. Understanding a Box Plot
Box plots help to easily
visualize the distribution
of benchmark survey data
#GlobalEQMS
27. PROCESS
HEALTH
Use of FMEA
and ECO
Supplier
Audits
Product
Compliance
CAPA
Closure
Customer
Complaints
Leading and Lagging KPIs
PROCESS
RESULTS
Engineering
Change
Orders
Supplier
Defect Rate
OEE
On Time
Shipments
Successful
NPI
#GlobalEQMS
33. Overall Equipment Effectiveness (OEE)
•Measures availability, efficiency, and quality (differs
by company)
•Must be put in context of supply chain
#GlobalEQMS
42. Successful New Product Introductions (NPI)
•Measures the number of new products introduced
hitting time, volume, and quality targets
#GlobalEQMS
43. Improving New Product Introductions (NPI)
•Establishing a formal risk management framework
improves median successful NPIs by >32%
#GlobalEQMS
44. Improving New Product Introductions (NPI)
•The ability to identify risk factors across operations
improves median successful NPIs by >24%
#GlobalEQMS
45. Improving New Product Introductions (NPI)
•Including suppliers in design for quality initiatives
improves median successful NPIs by >9%
#GlobalEQMS
46. Improving New Product Introductions (NPI)
•Establishing real-time visibility of quality metrics in
manufacturing improves median successful NPIs by >16%
#GlobalEQMS
47. Percentage of Products in Compliance
•Measures effectiveness of internal education
programs/SOPs
#GlobalEQMS
48. Improving Products in Compliance
•Easily understood compliance processes
improves median Products in Compliance by >5%
#GlobalEQMS
49. Improving Products in Compliance
•Establishing closed-loop processes to connect
improves median Products in Compliance by >3%
#GlobalEQMS
50. Improving Products in Compliance
•Establishing a formal NC/CAPA process improves
median Products in Compliance by >3%
#GlobalEQMS
51. Improving Products in Compliance
•Establishing a formal audit management process
improves median Products in Compliance by >3%
#GlobalEQMS
52. Recommendations for Success
•Define the role of quality in your
company’s strategic objectives.
•Identify the relationships between
leading and lagging KPIs across
the value chain
•Benchmark performance in KPIs
and track progress
•Create closed-loop quality
management process with EQMS
•Integrate quality business
processes, like: CAPA, Audit
Management, Risk Management,
and more
#GlobalEQMS
53. Thank You!!
For More Information -
Contact:
Matthew Littlefield
President and Principal Analyst
matthew.littlefield@lnsresearch.com
