This document discusses delivering GxP compliant mobile applications through a case study approach. It begins with an introduction to GxP mobile applications and what regulatory compliance means. Case studies are then presented that demonstrate different types of mobile applications and how they would be categorized and regulated. Key challenges discussed are classifying applications based on end use rather than technology, and different requirements from clients. The document advocates taking a pragmatic, risk-based approach focused on requirements, risk assessment, and test evidence. Ultimately, the intended use determines compliance needs rather than the platform itself.
11 Must-have Documents of Software Verification and Validationcomplianceonline123
This webinar focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. A suggested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples.
Implementing Agile in an FDA Regulated EnvironmentTechWell
Developing medical devices that are subject to FDA approval has traditionally followed the waterfall methodology, largely due to the structure of the regulations that govern development practices. But we know from myriad case studies in different industries that agile methodologies are far superior in providing the highest value to customers in the shortest time to market. Neal Herman shares how one developer of complex medical devices embraced agile software development practices and proved that it could not only develop software faster with higher quality but also meet all regulatory requirements. Convincing the internal quality management, systems engineering, and regulatory departments was difficult, but the software department was able to overcome these obstacles and fundamentally change the company’s philosophy on product development. Since 2012, software development productivity is up 100 percent, and quality is up 200 percent. Now, after seeing these gains from the software department, agile is being rolled out to all areas of R&D including hardware.
A Collection of DMN-Based CDSS for Sharable Clinical Guidelines - Bootstrappi...Denis Gagné
The goal of the BPM+ Health initiative is to accelerate the availability of industry-wide Sharable Clinical Pathways by reducing the communication barrier existing between clinicians and informaticians. The proposed solution will leverage a set of international standards from the OMG, namely BPMN, CMMN and DMN, known together as BPM+.
The success of the BPM+ Health initiative will be measured by the availability and adoption of its services. The communication barrier is being addressed via a “Field Guide” which provides methods and style recommendations to create unambiguous clinical guidelines. Wide availability of existing BPM+ models will drive adoption.
In this presentation we will introduce a comprehensive library of DMN clinical decisions services. These services can be easily consumed via API in any application. This initial catalog of DMN decisions services covers a wide range of clinical algorithms of general interest to clinicians.
FHIR North Automatable Clinical Guidelines with Open StandardsDenis Gagné
Presentation John Svirbely and Denis Gagne gave at the FHIR North 2020 conference.
An overview of the integration of BPM+ standards from OMG with HL7 FHIR and CDS Hooks to deliver visual guidelines that are both clinician friendly and automatable. A Diabetic Foot Infection example will be presented.
Modification after Initial Review and Transparency and Real-World Performance...EMMAIntl
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and transparency and real-world performance monitoring...
11 Must-have Documents of Software Verification and Validationcomplianceonline123
This webinar focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. A suggested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples.
Implementing Agile in an FDA Regulated EnvironmentTechWell
Developing medical devices that are subject to FDA approval has traditionally followed the waterfall methodology, largely due to the structure of the regulations that govern development practices. But we know from myriad case studies in different industries that agile methodologies are far superior in providing the highest value to customers in the shortest time to market. Neal Herman shares how one developer of complex medical devices embraced agile software development practices and proved that it could not only develop software faster with higher quality but also meet all regulatory requirements. Convincing the internal quality management, systems engineering, and regulatory departments was difficult, but the software department was able to overcome these obstacles and fundamentally change the company’s philosophy on product development. Since 2012, software development productivity is up 100 percent, and quality is up 200 percent. Now, after seeing these gains from the software department, agile is being rolled out to all areas of R&D including hardware.
A Collection of DMN-Based CDSS for Sharable Clinical Guidelines - Bootstrappi...Denis Gagné
The goal of the BPM+ Health initiative is to accelerate the availability of industry-wide Sharable Clinical Pathways by reducing the communication barrier existing between clinicians and informaticians. The proposed solution will leverage a set of international standards from the OMG, namely BPMN, CMMN and DMN, known together as BPM+.
The success of the BPM+ Health initiative will be measured by the availability and adoption of its services. The communication barrier is being addressed via a “Field Guide” which provides methods and style recommendations to create unambiguous clinical guidelines. Wide availability of existing BPM+ models will drive adoption.
In this presentation we will introduce a comprehensive library of DMN clinical decisions services. These services can be easily consumed via API in any application. This initial catalog of DMN decisions services covers a wide range of clinical algorithms of general interest to clinicians.
FHIR North Automatable Clinical Guidelines with Open StandardsDenis Gagné
Presentation John Svirbely and Denis Gagne gave at the FHIR North 2020 conference.
An overview of the integration of BPM+ standards from OMG with HL7 FHIR and CDS Hooks to deliver visual guidelines that are both clinician friendly and automatable. A Diabetic Foot Infection example will be presented.
Modification after Initial Review and Transparency and Real-World Performance...EMMAIntl
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and transparency and real-world performance monitoring...
NowPos M-Solutions Pvt. Ltd. NowPos is a Mobile Technology Development and Services company that specializes in custom solution development on various mobile platforms. Established in 2005, with offices in CA, USA and an offshore development center at Hyderabad, India, NowPos has over the years garnered expertise in developing mobile and web based solutions for industry verticals such as mobile based Advertising, Healthcare (mHealth), Patient Care and information capturing (m-PRO), Entertainment and Media, supported by robust web platforms.
This presentation tells in brief the solutions provided by Impetus\'s Testing Center of Excellence "qLabs". Please send in your comments at qLabs@impetus.co.in
http://www.impetus.com/qLabs
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...Greenlight Guru
FDA caused quite a stir when it announced transformative changes to modernize its 510(k) program to improve the safety and effectiveness of medical devices.
But as we all know, the more things change, the more they stay the same. If you dive deep into FDA’s statement, you’ll realize that there’s probably not a lot that’s different.
In this session, Michael Drues, Ph.D., President of Vascular Sciences, will share what FDA's 510(k) Modernization means, any evidence that changes are happening, and what medical device manufactures need to know about 510k modernization.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Evolving healthcare trends coupled with a slew of new features and functions to consider can overwhelm anyone charged with the task. Case managers typically are not been involved in the selection process, but that seems to be changing as organizations realize their input can be useful when it comes to choosing the most effective and efficient system.
Case managers who do get this opportunity can be prepared by staying up-to-date on the latest healthcare trends and technology that impact medical management functionality. While it is difficult to keep up with the expanding symbiotic interface between technology and care management workflow processes, case managers must understand how technology solutions can improve processes and patient outcomes.
Orthopedic Surgery Preauthorization Automated Guidelines for Healthcare Rei...Denis Gagné
Preauthorization can be a source of stress for patients and providers. It is difficult to keep up with the changes made by different insurers, and there is the threat of criminal prosecution. In the first webinar, we will give an example of a routine preauthorization for an orthopedic surgical procedure - first total knee arthroplasty. The burden for providers can be reduced by integrating preauthorization with models used to prepare the patient for surgery.
Software testing solutions have resulted in an always successful implementation of the software.
As a Quality Assurance testing company across the IT life cycle of key banking domains such as retail banking, corporate banking, payments, multi-channel, wealth management, regulatory compliance and equities, these service providers have to ensure scalability for their clients
Regulatory strategy for medical device start-upsRina Nir
If you are a medical device entrepreneur thinking how to take regulatory requirements into account when creating your business plan, you might find this presentation useful.
This presentation was given at a TTC round table event in Maastricht, NL.
What’s happening in Banking World?
The entire landscape is very competitive and banks today are evolving. Banks are relying more and more on technology to reach customers and deliver services in short span of time. It is becoming important for them to be consistent and deliver quality customer services using technology to reach, expand and deliver faster and better services.
Adding additional services and transactions via technology, integrating with legacy systems and delivering using new delivery methods are becoming a norm. The banking industry is embracing newer technology to grow their market share. With technology, banks today are global players and no more local.
Challenges
Challenges in the multiple industries are similar but in Banking, there are specific challenges, which makes it unique, which are
• Frequently changing market and regulatory requirements
• High data confidentiality requirements
• Complex system landscapes including legacy systems
• Newer technologies such as mobile and web services
• Enterprise banking integration – Core banking, Corporate Banking and Retail Banking
• Application performance – Internal and External
Approaches to meet the challenges
It is very important that banks and financial establishments conduct regression tests over the entire application lifecycle for every release and also maintain test suites for each release using effective version control system linked to requirements, test cases, test scenarios and realistic test data. Based on this, an effective testing approach can be taken individually or by combination of the following to achieve the desired results:
• Risk-based testing
• Automation - Legacy, Web, Mobile
• Test data management
• Compliance / Statutory testing
• Performance and Capacity engineering
• Off-shoring
Bridging User Needs & Design Requirements: Answers are Only as Good as the Qu...Greenlight Guru
We did the surgery perfectly, yet the patient died anyway… we designed the medical device perfectly, yet the patient died anyway… we followed the regulation perfectly, yet the patient died anyway.
All are iterations on the same theme, i.e., all have the same root cause: answers are only as good as the questions we ask!
Or put another way: what good is designing the right medical device if we are solving the wrong problem?
Is regulatory and quality simply about making sure your design inputs match your user needs, i.e., ticking the boxes? What if your user needs are wrong? Do we need regulation to require us to make sure we are solving the right problems? asking the right questions?
Regulation is all about the interpretation of words and your ability to defend your interpretation.
Using the case study approach, this presentation will cover:
-What is a design input and how do we make sure we have the right ones?
-What's the relationship between design inputs and user needs?
-How do we turn “user inputs” into a viable product and more importantly the right product!
-How do we “translate” user needs to design requirements? Can regs helps?
-How to read between the lines of user feedback, i.e., wants vs. needs?
-How do we sync design requirements and user needs?
-What are the challenges for the future?
Learn more, and watch the presentation, here: https://www.greenlight.guru/webinar/bridging-user-needs-design-requirements
Integrated Drug Safety Business and Technology Solution Delivers Operational ...Covance
A leading specialty pharmaceutical medicines company were rethinking their safety technology and operations strategy and needed an end-to-end safety technology solution that would include the expertise of medical information, a contact center, case processing, aggregate reporting, signal management and risk management.
Healthcare App Testing - Make Your App FlawlessBugRaptors
We have almost entered in an era where applications monitor our lives. Starting from a primary BP machine to conventional angiography, we depend upon application and digital devices. This makes testing of healthcare mobile apps more crucial than ever. Check out the PPT to know more about healthcare app testing.
The case study describes a best practices approach to the development of a whole product roadmap for laboratory information management system (LIMS) software to support next-generation sequencing (NGS) for translational and clinical genomic research.
NowPos M-Solutions Pvt. Ltd. NowPos is a Mobile Technology Development and Services company that specializes in custom solution development on various mobile platforms. Established in 2005, with offices in CA, USA and an offshore development center at Hyderabad, India, NowPos has over the years garnered expertise in developing mobile and web based solutions for industry verticals such as mobile based Advertising, Healthcare (mHealth), Patient Care and information capturing (m-PRO), Entertainment and Media, supported by robust web platforms.
This presentation tells in brief the solutions provided by Impetus\'s Testing Center of Excellence "qLabs". Please send in your comments at qLabs@impetus.co.in
http://www.impetus.com/qLabs
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...Greenlight Guru
FDA caused quite a stir when it announced transformative changes to modernize its 510(k) program to improve the safety and effectiveness of medical devices.
But as we all know, the more things change, the more they stay the same. If you dive deep into FDA’s statement, you’ll realize that there’s probably not a lot that’s different.
In this session, Michael Drues, Ph.D., President of Vascular Sciences, will share what FDA's 510(k) Modernization means, any evidence that changes are happening, and what medical device manufactures need to know about 510k modernization.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Evolving healthcare trends coupled with a slew of new features and functions to consider can overwhelm anyone charged with the task. Case managers typically are not been involved in the selection process, but that seems to be changing as organizations realize their input can be useful when it comes to choosing the most effective and efficient system.
Case managers who do get this opportunity can be prepared by staying up-to-date on the latest healthcare trends and technology that impact medical management functionality. While it is difficult to keep up with the expanding symbiotic interface between technology and care management workflow processes, case managers must understand how technology solutions can improve processes and patient outcomes.
Orthopedic Surgery Preauthorization Automated Guidelines for Healthcare Rei...Denis Gagné
Preauthorization can be a source of stress for patients and providers. It is difficult to keep up with the changes made by different insurers, and there is the threat of criminal prosecution. In the first webinar, we will give an example of a routine preauthorization for an orthopedic surgical procedure - first total knee arthroplasty. The burden for providers can be reduced by integrating preauthorization with models used to prepare the patient for surgery.
Software testing solutions have resulted in an always successful implementation of the software.
As a Quality Assurance testing company across the IT life cycle of key banking domains such as retail banking, corporate banking, payments, multi-channel, wealth management, regulatory compliance and equities, these service providers have to ensure scalability for their clients
Regulatory strategy for medical device start-upsRina Nir
If you are a medical device entrepreneur thinking how to take regulatory requirements into account when creating your business plan, you might find this presentation useful.
This presentation was given at a TTC round table event in Maastricht, NL.
What’s happening in Banking World?
The entire landscape is very competitive and banks today are evolving. Banks are relying more and more on technology to reach customers and deliver services in short span of time. It is becoming important for them to be consistent and deliver quality customer services using technology to reach, expand and deliver faster and better services.
Adding additional services and transactions via technology, integrating with legacy systems and delivering using new delivery methods are becoming a norm. The banking industry is embracing newer technology to grow their market share. With technology, banks today are global players and no more local.
Challenges
Challenges in the multiple industries are similar but in Banking, there are specific challenges, which makes it unique, which are
• Frequently changing market and regulatory requirements
• High data confidentiality requirements
• Complex system landscapes including legacy systems
• Newer technologies such as mobile and web services
• Enterprise banking integration – Core banking, Corporate Banking and Retail Banking
• Application performance – Internal and External
Approaches to meet the challenges
It is very important that banks and financial establishments conduct regression tests over the entire application lifecycle for every release and also maintain test suites for each release using effective version control system linked to requirements, test cases, test scenarios and realistic test data. Based on this, an effective testing approach can be taken individually or by combination of the following to achieve the desired results:
• Risk-based testing
• Automation - Legacy, Web, Mobile
• Test data management
• Compliance / Statutory testing
• Performance and Capacity engineering
• Off-shoring
Bridging User Needs & Design Requirements: Answers are Only as Good as the Qu...Greenlight Guru
We did the surgery perfectly, yet the patient died anyway… we designed the medical device perfectly, yet the patient died anyway… we followed the regulation perfectly, yet the patient died anyway.
All are iterations on the same theme, i.e., all have the same root cause: answers are only as good as the questions we ask!
Or put another way: what good is designing the right medical device if we are solving the wrong problem?
Is regulatory and quality simply about making sure your design inputs match your user needs, i.e., ticking the boxes? What if your user needs are wrong? Do we need regulation to require us to make sure we are solving the right problems? asking the right questions?
Regulation is all about the interpretation of words and your ability to defend your interpretation.
Using the case study approach, this presentation will cover:
-What is a design input and how do we make sure we have the right ones?
-What's the relationship between design inputs and user needs?
-How do we turn “user inputs” into a viable product and more importantly the right product!
-How do we “translate” user needs to design requirements? Can regs helps?
-How to read between the lines of user feedback, i.e., wants vs. needs?
-How do we sync design requirements and user needs?
-What are the challenges for the future?
Learn more, and watch the presentation, here: https://www.greenlight.guru/webinar/bridging-user-needs-design-requirements
Integrated Drug Safety Business and Technology Solution Delivers Operational ...Covance
A leading specialty pharmaceutical medicines company were rethinking their safety technology and operations strategy and needed an end-to-end safety technology solution that would include the expertise of medical information, a contact center, case processing, aggregate reporting, signal management and risk management.
Healthcare App Testing - Make Your App FlawlessBugRaptors
We have almost entered in an era where applications monitor our lives. Starting from a primary BP machine to conventional angiography, we depend upon application and digital devices. This makes testing of healthcare mobile apps more crucial than ever. Check out the PPT to know more about healthcare app testing.
The case study describes a best practices approach to the development of a whole product roadmap for laboratory information management system (LIMS) software to support next-generation sequencing (NGS) for translational and clinical genomic research.
Guide to Develop a Healthcare App Like Epic Systems Corporation.pdfMariaMurphy57
One such trailblazer in the realm of healthcare technology is Epic Systems Corporation, renowned for its innovative healthcare software solutions.
Visit: https://www.quytech.com/healthcare-app-development.php
The medical device industry is facing unprecedented challenges due to emerging technologies and increased regulatory scrutiny.
Current “waterfall” product development methods are ill-suited to dealing with the pace of change and uncertainty that product development organizations are facing. This eBook addresses:
* The shortcomings of waterfall development specifically in regulatory environments.
* How agile development meets the safety, reliability and regulatory needs of the medical device and diagnostics industry.
* How agile development can help ensure delivery of successful software.
Step-by-Step Guide How to Create an App Like Saudi German Health.pdfTechgropse Pvt.Ltd.
Get in Contact with us today for app developers in Riyadh,
If you're a healthcare provider, entrepreneur, or developer interested in creating a similar app, this step-by-step guide will walk you through the process, focusing on the unique challenges and opportunities of a mobile app development company in Saudi Arabia
Simplifying Postmarket Surveillance: Introducing Veeva Vault Product Surveill...Eric Burniche, MBA
To watch the full webinar:
The growing complexity of medical products and rapidly changing global regulations require a more holistic and consistent approach to postmarket surveillance (PMS).
However, disconnected and highly-customized solutions - historically serving med-tech companies - have fallen short of meeting the evolving needs of the industry.
Can your PMS system quickly adapt to regulatory changes and enable you to meet global submission timelines?
In this webinar, Carl Ning, Sr Director of Strategy at Veeva systems, discusses recent trends driving organizations to transform systems and processes for better product quality and reliability. You will also hear about Veeva Vault Product Surveillance, Veeva’s new application that simplifies and standardizes global postmarket surveillance.
Attend the webinar to learn:
- How to address common challenges in managing complaints and submissions
- How a unified approach to postmarket surveillance streamlines end-to-end quality management
- How Vault Product Surveillance standardizes and consolidates the complaint reportability process for various health authorities
Simplifying Postmarket Surveillance: Introducing Veeva Vault Product Surveill...Veeva Systems
To watch the full webinar:
The growing complexity of medical products and rapidly changing global regulations require a more holistic and consistent approach to postmarket surveillance (PMS).
However, disconnected and highly-customized solutions - historically serving med-tech companies - have fallen short of meeting the evolving needs of the industry.
Can your PMS system quickly adapt to regulatory changes and enable you to meet global submission timelines?
In this webinar, Carl Ning, Sr Director of Strategy at Veeva systems, discusses recent trends driving organizations to transform systems and processes for better product quality and reliability. You will also hear about Veeva Vault Product Surveillance, Veeva’s new application that simplifies and standardizes global postmarket surveillance.
Attend the webinar to learn:
- How to address common challenges in managing complaints and submissions
- How a unified approach to postmarket surveillance streamlines end-to-end quality management
- How Vault Product Surveillance standardizes and consolidates the complaint reportability process for various health authorities
Selecting an App Security Testing Partner: An eGuideHCLSoftware
In the age of digital transformation, global businesses leverage web application scanning tools to shape innovative employee cultures, business processes, and customer experiences. The surge in remote work, cloud computing, and online services unveils unprecedented vulnerabilities and threats.
Learn more: https://hclsw.co/ftpwvz
Procuring an Application Security Testing PartnerHCLSoftware
Procuring an Application Security Testing Partner is crucial for safeguarding digital assets. An Application Security Testing Partner specializes in conducting comprehensive assessments using keywords like vulnerability scanning, penetration testing, code review, and threat modeling. Their expertise ensures your applications are fortified against cyber threats, providing peace of mind in an increasingly interconnected digital landscape.
Learn More: https://hclsw.co/ftpwvz
RapidValue White Paper on Regulations and compliance for enterprise mHealth a...Nageena Vijayan
Healthcare organizations and software firms looking to make investments in mobile applications need to assess implications of HIPAA and FDA in order to protect patient health information and
ensure compliances are met. This document outlines some of the key evaluation criteria on regulations and security considerations in healthcare sector that need to be addressed while
implementing mobility applications.
5 Tips to Go for Performance Testing Tools.pdfRohitBhandari66
In the rapidly evolving realm of software development, developing high-performing apps is now an absolute must. Organizations must give performance testing top priority in order to make sure their software systems can survive the rigors of today’s computing environments, given the rising expectations of users and the fiercer competition.
Innovation Showcase: Top Healthcare Apps Built on Salesforce App CloudDreamforce
Join us to hear how top health and life science companies are using Salesforce App Cloud to accelerate app development, tackle new challenges, and innovate across their entire organization. Watch the video now: https://www.youtube.com/watch?v=VNWra_JL-FY
Overcoming Cloud-Based Mobility Challenges in HealthcareAnyPresence
April Sage of Online Tech and Rich Mendis of AnyPresence review the common challenges associated with mobile enablement, and introduced the new technologies that are empowering healthcare providers to securely engage their patients and practitioners through the mobile channel.
Quality Assurance and mobile applications!Bagaria Swati
Quality assurance is the planned and systematic set of activities that ensures that software processes and products conform to requirements, standards, and procedures.
Processes include all of the activities involved in designing, developing, enhancing, and maintaining software.
Products include the software, associated data, its documentation, and all supporting and reporting paperwork.
QA includes the process of assuring that standards and procedures are established and are followed throughout the software development lifecycle.
Standards are the established criteria to which the software products are compared.
Procedures are the established criteria to which the development and control processes are compared.
Compliance with established requirements, standards, and procedures is evaluated through process monitoring, product evaluation, audits, and testing.
The three mutually supportive activities involved in the software development lifecycle are management, engineering, and quality assurance.
Software management is the set of activities involved in planning, controlling, and directing the software project.
Quality assurance at CodeMyMobile is a high priority and forms an integral part of our Mobile app development lifecycle.
2. Disclaimer
The views and opinions expressed in the following PowerPoint slides are
those of the individual presenter and should not be attributed to Drug
Information Association, Inc. (“DIA”), its directors, officers, employees,
volunteers, members, chapters, councils, Special Interest Area
Communities or affiliates, or any organisation with which the presenter is
employed or affiliated.
These PowerPoint slides are the intellectual property of the individual
presenter and are protected under the copyright laws of the United States of
America and other countries. Used by permission. All rights reserved. Drug
Information Association, DIA and DIA logo are registered trademarks or
trademarks of Drug Information Association Inc. All other trademarks are
the property of their respective owners.
4. Approach
Perspective of delivering solutions for
commercial projects
High-level overview of compliance, technology
and business process challenges
Experience of service provider, mobile
application development and sponsor
5. Introducing the speaker
Mark Stevens
Chemical Engineer
Pharma / Biotech / Food
Design, construction,
validation, CSV, clinical,
QMS, demolition
Remediation, compliance
improvement and new
technology introduction
6. GxP mobile application experience
Since 2007
Global mobile network provider
Cold chain supply
Mobile app developers to blue-chip
corporations
Hosted data centre providers
SaaS providers
7. The opportunity
Rapidly emerging technology with clear
business benefits:
• Cost
• Accessibility and availability
• Converging / Combination health solutions
• Competitive advantage
8. The challenge
Maintain patient safety, data integrity and security
What is ‘GxP compliance’?
New technologies, development methods and service
providers
Ownership and responsibility of data
Inconsistent terminology across regulations, guidelines
and organisations
9. What is a mobile GxP application?
Who? Use Case Data Capture
Patient
Health Care
Professional
Pharma co
Medical
Device co
Non-critical
action
Patient
compliance
Critical action
Data trending
Combination
Survey
Qualitative –
e.g. wellbeing
Quantitative
transcribed
Quantitative
automated
Pharmacov.
10. Categorisation?
Non-validated system
Lifestyle / Wellbeing
Marketing
Validated Information
System
Infrastructure
Interface / Portal
Medical Device Class I
Component
Data transmission
Application
Medical Device Class II
Component
Data transmission
Application
Combination:
System / Device
11. What is a mobile GxP application?
Many things to many different people, even
within a single organisation
Rapidly changing
Existing applications evolving
Something relatively unknown from a
regulatory compliance perspective
12. How do we achieve GxP compliance?
Industry guidance, e.g. GAMP® A Risk-Based
Approach to Regulated Mobile Applications
End use driven. What is it being used for?
Apply the knowledge and risk-based
approaches you already use
Keep it simple!
14. Case Study 1
Development of a mobile application ‘platform’
to be offered to multiple clients
Matrix of users, use cases, data being
captured, transaction types and novelty of
approach
Variability of end-use (application) the biggest
factor by far
15. Case Study 2
Mobile App receiving data
from a Medical Device worn
by the Patient
Data also entered by patient
Data received on central
database. Viewed and acted
upon by Healthcare
Professionals
The App is clearly seen as part of a Medical Device
Data System (MDDS) for regulatory purposes
The “Class” of Device and System is dependent on
how the sensing / monitoring part of the device is
used and how the information is used, not the
nature of Mobile App software
16. Case Study 3
Mobile App using data
entered by patient concerning
drugs, doses and symptoms
Data received on central
database. Used to monitor
adherence to medication
regime
Version 1 of the App will not be classed as a Medical
Device, but…
Developing and Documenting the App as a potential Medical Device
(future versions by be connected to monitoring devices)
Developing the central database as a potential
validated computerised system (dependent upon
future end-use)
17. Our experience from commercial projects
Classification of Devices and Systems being
driven by end use, rather than complexity of
technology
Regulated company taking the view of
developing with potential future use in mind
Reluctance to make claims of mobile
applications as medical devices / validated
systems due to the anticipated delays,
complexity and cost
18. Our experience from commercial projects
Projects often evolve from (unregulated) proof of
concept to pilot study without robust challenge of
requirements specification
Multiple client groups involved during development
lifecycle – often with different or inconsistent
requirements
Significant reliance on vendors to understand and
achieve customer-specific regulatory requirements
Great results and success are being achieved when
there is a high level of collaboration between vendors
and regulated customer
19. Who is responsible for what?
GAMP5® definition of responsibilities still works
well
Regulated Company responsible for
regulatory status / classification / risks of their
“product” based upon end-use
Supplier (e.g. Mobile App Developer)
responsible for developing and documenting
their software in a way that meets guidelines
and best practice
20. Regulated company viewpoint
A defined CSV process
A defined Medical Device Design process
Use the existing Supplier Approval / Audit
process
Meet requirements of established processes
within the corporation
21. Mobile App vendor viewpoint
What is ‘GxP Compliance’?
Life science want a QMS and (more) documentation in
a familiar format
Each App may have significant differences in
requirements (end use)
Each client can have differing requirements. Why?
This is only one market vertical – it needs to be cost-
effective to support this business
22. What is it we are looking to achieve?
We are developing new Devices and new
Systems where the end use may still be
unclear or open
We are engaging with new partners and
technology providers in order to realise these
…so we need to approach things in a
pragmatic way that reflects this.
23. Commercial reality
Both parties need to compromise on standard
processes and documentation
Technology changing faster than regulations – precise
regulatory classification sometimes difficult
Waterfall vs. Agile Development – Agile can be
perfectly acceptable
Define and agree the requirements for each project –
end use is the driver
24. What do we need to validate?
What is the App actually being used for?
If it goes wrong, could anyone be hurt?
Risk Assessment
Is it (part of) a Medical Device?
Is it (part of) a Validated System?
25. Planning for success
Defining Requirements in a traceable and testable
manner
Good Design Documents that help future maintenance
Risk-based testing of software, with evidence recorded
Testing on the right platform(s)
WiKi / SaaS / Agile / Cloud-based applications can
achieve what we need!
Roadmap – future use?
26. Summary
Mobile applications offer huge patient and business
benefits in GxP applications
Compromise between existing computer compliance
and medical device development, testing and records
Focus on the important stuff – Requirements Spec.,
Risk Assessment, Trace Matrix, Test evidence
GxP compliance is driven by the end use
Often the ultimate use of the mobile application may be
different from the original project brief