AbbV Mobile Solutions - QA Strategy

Transcript

1. Mobile Solutions QA Strategy - Recommendations October 27, 2014
2. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› • Project Timeline • QA - Pain Points & Gaps • QA Strategy • Mobile App Type Classification • Development Guidelines • Validation Process • Change Impacts • Change Implementation & Roadmap • Next Steps Agenda Mobile Solutions QA Strategy | 10/27/14
3. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› Project Timeline Phase July August September October Outcome Curre nt State Audit Interview Stakeholders Current State Audit - Pain Points - Gaps - Organizational View - Processes Review Mobile App and existing documentation Document pain point and gaps QA Strate gy Guidelines for Mobile App QA Future State QA Strategy - Criteria for QA - Key success factors - Recommendations Recos for leading class Mobile QA Org Strate gy & Orche strati on Future State Org Structure Future State Org Structure - Operational Model - Orchestration use cases - Detailed function and role descriptions Define key functions and roles Develop high level org processes for FS We are here Mobile Solutions QA Strategy | 10/27/14
4. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› • Mobile app classification is currently ambiguous based on entrance into medical devices • Long validation timelines based on SQA process to test all aspects of mobile apps provided to quality group within design history file • Supplier’s are not pre-audited or provided guidelines and standards for mobile app development • Missing capability to re-use validated code for similar features (e.g. dosage calculator) or foundational code base QA - Pain Points and Gaps Mobile Solutions QA Strategy | 10/27/14
5. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› 1. Mobile App Classification Process - Questionnaire / Decision Tree to determine Mobile App type - Available through MCoP / IT / Quality Intranet Sites for self service - Workflow to downstream groups (IT/MCoP & Quality) to follow up, answer questions and final verification of mobile app type 2. Development guidelines for mobile apps - Follow best practices for mobile app development with partitioned code for key areas of mobile app architecture - Update existing process with Commercial & IT to determine which parts of mobile app should be tested by Commercial, IT & Quality 3. QA Execution Standards - Transitioning to a shared testing process with business, IT, and vendors (where appropriate) QA – Strategy Solutions Mobile Solutions QA Strategy | 10/27/14
6. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› Mobile Solutions QA Strategy | 10/27/14 • Standardize a questionnaire or form, which will determine app type or directionally provide enough information to be vetted by IT, MCoP, and Quality: Mobile App Classification Process 1 What is the basic functions of your mobile app? ‒ Provide Static Content ‒ Collect Data ‒ Support the administration of the ‒ Other: Details 2 Who will be the users of this app? ‒ Consumers/
 Patients ‒ Clinicians ‒ Medical Professionals ‒ Internal AbbVie 3 Which Mobile OS need support? ‒ iOS ‒ Android ‒ Windows Phone 4 Which native Smartphone capabilities are being used? ‒ Camera ‒ GPS ‒ Data store 5 Are you storing any data any user provided data on the phone? ‒ Yes ‒ No ‒ TBD If yes, what will be done with the data? ‒ Stored for reuse ‒ Send to shared server / cloud If yes, What kind of data? ‒ Patient Information ‒ ???? ‒ ???? What is the use of the data Analysis for research App Usage Other 6 Who is the vendor selected for this app? ‒ Vendor ‒ TBD ‒ AbbVie IT 7 Will the app take any input and provide an output for the application of the drug? ‒ Yes ‒ No ‒ TBD 8 Does the App provide any instruction that differs from drug insert? ‒ Yes ‒ No ‒ TBD 9 Which countries will this app be deployed in? ILLUSTRATIVE
7. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› • Deploying the Mobile App classification content will be key for usage and adherence - Leveraging the MCoP Global and Digital CoE Intranet sites are ideal options: - Also providing awareness to the enterprise through email and direct relationships with Commercial and IT Mobile App Classification Process MCoP General Mobile Content for devices apps, etc.. Mobile Handset Request Mobile App Development Support Mobile Web Support Mobile App Support Mobile App News & Trends Mobile App Request Form Preferred Vendors Mobile Development Guidance Documents Mobile App Request Form FDA Content MCoP / Digital COE Intranet Sites Mobile App Intranet Site Web Based Form for Mobile App Classification Mobile Solutions QA Strategy | 10/27/14
8. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› • Developing a workflow can significantly increase the process for classification and/or vetting for Mobile App or Web or understanding business purpose: Mobile App Classification Process Commercial Submits form: Brochure App? Follow existing MCoP Process Content from Mobile App form is reviewed by Quality Reviewed with IT and/ or Commercial Group Potential Medical Device? Medical Device QA Reviews details: Medical Device QA provides guidance for app features and func. Mobile App guidance for data, vendors, reuse is provided Yes Yes No Commercial Commercial IT QA Conduct Additional Reviews with Commercial & IT for more details No Mobile Solutions QA Strategy | 10/27/14
9. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› • Best practices for Mobile App development partition code into sections: • While each layer of the of the code requires testing, quality can focus primarily on the layers that affect features and functionality that qualify the app as a medical device and/or expose the firm to compliance and/or regulatory risk (e.g. security, data collection, T&C’s, content) • By following this code structure the opportunity exists to re-use validated code for future apps with similar features and functions Development Guidelines for Mobile Apps Presentation Layer Application Layer Data Layer Foundational / Platform Layer Mobile Solutions QA Strategy | 10/27/14
10. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› Model View Controller Architecture Controller Generic Logic View Model 3rd Party HWSW Application Data Changes Update Changes Update • Device Apps should follow a standard architecture enabling Device QA to focus on critical logic only Medical Device Functions Proposed Scope of Device QA’s Focus • Controller Logic should be partitioned to separate medical algorithms from basic app functionality • The DHF structure should be adjusted to account for this change in development/QA • Presentation, Application, and Data Layer are interchangeable terms for View, Controller, and Model respectively Mobile Solutions QA Strategy | 10/27/14
11. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› Recommended Objective-C/Swift (iOS8) Application Code Structure • Device Apps should follow a standard architecture enabling Device QA to focus on critical logic only • Medical Device Controller logic can be stored in a separate file making it completely self contained. Version control of this file can then be easily monitored by device QA View Logic Device Controller Logic* Generic Controller Logic Data Layer Logic *Same code structure applies to Java based apps for Android Mobile Solutions QA Strategy | 10/27/14
12. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› 
 Shared QA responsibility for Mobile Apps Quality Check Commercial IT QA QA Commercial Product Owner Vendor Unit tests (all apps) R I I A,S,C Unit tests (medical device) I R,A I C Integration (all apps) R I I A,S,C Integration (medical device) I R,A I C Cross device compatibility R C,I A,S,C OS version compatibility C R A,S,C Apple HIG’s A,C R,I A Performance (energy consumption, network connectivity) R,I,C I A OS Integrations (calendar/ contacts access) R C,I A Security R S C,I A Human Factors ? ? ? ? Regression Testing ? ? ? ? KEY: Responsible - ownership to complete a task Accountable –Approver of initiative/activity Support - Works for the Responsible party for completion of activity Consulted Informed Mobile Solutions QA Strategy | 10/27/14
13. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› Current State: Future State: Change Impacts to QA End-to-End timeline Planning & Reqs Design & Development Test / QA Deploy Timeline of “X months” based on small sample size * Zempro 14 mos (1st medical device app) * Missing of dev guidelines for mobile * QA Engaged late in process Planning & Reqs Design & Development Test / QA Deploy Implementation of QA Strategy Recommendations could reduce timelines significantly (~25%-40%) • Web based request form • Workflow based response w/commercial • Defined development guidelines per mobile app best practices • Isolation of code for regulatory and compliance exposure • Shared responsibility of testing with Commercial IT and Vendors • Reduce duplication of testing of visual and non-computation aspects of mobile apps Mobile Solutions QA Strategy | 10/27/14
14. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› • Identifying the correct Change Agent? - Changes to development guidelines and sharing testing responsibilities with commercial, IT and external partners will require a partner, ideally within Commercial IT - Typically QA does not provide development guidelines to IT, but regulatory and speed to market can be justifiable drivers • Implementing change within QA will require time and resources - Focused change resources will be needed to baseline standards and guidelines, work with commercial, IT groups to implement and to maintain content and provide communications to the enterprise Considerations for implementing change? Mobile Solutions QA Strategy | 10/27/14
15. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› • Communication to enterprise that within 6-9 months QA has identified and implemented changes to reduce end to end timelines to plan, build, test, and deploy mobile apps (medical or non-medical devices) • Business should not feel stifled from medical device classification for optimal “Care Experience” Roadmap for Change 2014 Q4 2015 Q1 2015 Q2 2015 Q3 2015 Q4 Baseline Mobile App Classification Develop Mobile App Software Guidelines Implement Changes with Commercial IT Develop Workflow & Web Form Partner with Commercial IT for Development and Testing Changes QA Strategy Changes Org Changes TBD Mobile Solutions QA Strategy | 10/27/14
16. Mobile Solutions QA Strategy | 10.15.14 | Company Confidential © 2014 ‹#› • Finalize QA Strategy Deliverable • Develop Options for Org Strategy Changes • Schedule Reviews for Org Recommendations Next Steps Mobile Solutions QA Strategy | 10/27/14