Challenges of Software Testing in the Life Sciences

Copyright SmarteSoft 2017 18 May 2017
Inflectra Boston User Summit
2017

Agenda & Objectives
Copyright SmarteSoft 2016
 Agenda
 About SmarteSoft
 Today’s Life Sciences QA Needs
 Case Studies
 Q&A

About SmarteSoft
 Founded 1999 as AccordSQA to provide a better way of test
automation
 Funded by Ariya International, founder’s QA consulting firm
 Provide Functional, Unit and Load Test, and Application/Test Lifecycle
Management Solutions
 First products 2004
 Recapitalized and re-launched October 2007 as SmarteSoft
 HQ in Austin, TX
 Multiple offices worldwide
 New leadership effective 2015
 Specialized capabilities in the Life Sciences markets

Who uses SmarteSoft ?
 Every size of enterprise, from startup to Fortune 100
 Bi-modal market sweet spots: both SMBs and $500M-$5B enterprise
 Daily inquiries by Global 1000 firms
 Broad range of industries
 Generally agnostic to industry verticals
 More frequent interest in migrating from previous standards like HP
 Especially expert in the healthcare market
 Geographics
 North America represents about 70% of revenue
 Strong business growth in Europe, APAC
 Budding business in Middle East
 About 50/50 split between IT and software R&D teams
 About 40/60 split between on-premise and web apps (Cloud and SaaS)

Life Sciences Markets
 Health Care Providers
 Acute Care
 Community and Ambulatory
 Pharmacies and Clinics
 Assisted Living
 Home-Based Care
 Health Care Payers
 Insurance Companies (BCBS, Tufts, etc.)
 Self-Insured Providers (Kaiser, Ascension, etc.)
 Pharmaceutical
 Drug R&D, Manufacturing
 Clinical Trial
 Dispensary Process Validation

 Rapise for all forms of functional testing:
 Regression
 Validation
 Unit
 Integration
 The ‘Spira’ family of products for:
 Requirements, Test and Defect Management
 Project Management
 Application Lifecycle Management (ALM)
The Product Recipe

The Healthcare Provider Dilemma
 Complex and shifting regulatory and attestation needs
 Heavily regulated industry – HIPAA, FDA, CAP, and others
 Meeting with MU, Medicare, Medicaid, etc. attestation now critical margin element
 Healthcare Information Systems (HIS, EMR) ever-growing in complexity and scale
 HIS brings added volatility to the hospital ROI equation
 Through traditional manual approach, often validation and regression testing ultimately is for the sake of
testing – and ritual -- not comprehensive understanding of system performance. Lack of focus on
causality, risk mitigation and optimized economics
 Investments in new HIS are immense with no standardized way to manage quality
 Litigation-free environment (“learned intermediaries”) and absence of regulatory oversight exacerbates
functionality problems
 QA resources often re-prioritized
 Traditional test automation “tool” schemes require resources that are generally not available in this space;
functional testing, manual or automated, not ideal fit for clinicians

SmarteSoft Healthcare Technology
“Database Analytics”
• Assess rule
sets,
configurations,
user
customizations
• Understand
build version
variability
• Functional
testing
normalization
Build Reconciliation
• Validate
relational
integrity
• Isolate critical
rule set
misalignment
• Database
compares
• Isolate
typographics
Functional Testing
• Normalization
allows for
dramatically
more rapid and
comprehensive
testing
• Automated
regression
testing
• SLA assurance

More Than Just Healthcare
Nearly all standardized enterprise application
suites (SAP, Lawson, Cerner, etc.) are a core
application with overall functionality dependent on
two layers of often-changing Configuration (rule
sets) and User (order catalogs, SKUs, user
profiles, etc.) Data.
 Leveraging this data to normalize the test
environment allows for true menu-driven script-less
functional testing
 Test coverage becomes exponentially greater, and
time to test is driven to an absolute minimum
 Regression testing automatically adjusts for changes,
realizing full automation of this ALM cycle element.
Understanding changes in release performance is
virtually immediate
 Complete understanding of application functional
performance is now possible, assuring the maximum
application ROI and end-user experience
Hyper-efficient Smarte testing

SmarteSoft in Healthcare
 Regulatory and testing
 Validation, unit, and regression testing
 Automatized migration from manual testing to automated
 Integration testing
 Blood bank and other rigorous Validations, complete with digital signature capabilities
 Application maintenance and patch release testing management
 HIS investment ROI optimization
 Resolution of code instability errors
 Build/Mock/Test domain and database reconciliation vs each other or Prod
 Database error analysis
 System audits and risk mitigation efforts
 Assure complete revenue realization
 Application quality assurance (SLA governance)
 Clinical resource prioritization
 Domain population for testing and training purposes
 CDS optimization
 Protection against potential added legal responsibility associated with remiss software due to increased documentation and
error traceability1
1. Newport Group, Justifying the Purchase of an Automated Testing Tool

Healthcare Case Studies
Ascension Health
 85 Acute care facilities, Central and Eastern U.S.
 $21BB annual revenue
 Smarte QA approach identified and saved 0.46% of revenue annually
Kaiser Permanente
 201 Acute care facilities across Western and Central U.S.
 Application (Blood Bank, Pharmacy, Laboratory, etc.) upgraded at every facility on an average 18-
month interval
 Smarte QA approach saved approximately $400K per application upgrade
Tenet Health
 Publically-traded 108 Acute care facilities across U.S. and Europe
 Smarte QA approach saved $1MM monthly in pharmacy charge errors for each of their Texas
facilities

The Healthcare Payer Dilemma
 Traceability and Reconciliation
 Medicare and Medicaid, MU
 Value for service
 Unnecessary treatment expenditures
 Healthcare Information Systems (HIS, EMR) ever-growing in complexity and scale
 Reconciliation between EMR and ERP
 Administrative Flux
 Back office and BPO continuously changing in an effort to optimize revenue cycles, keep
pace with legislative changes
 QA resources often re-prioritized
 Traditional test automation “tool” schemes require resources that are generally not available
in this space; functional testing, manual or automated, not ideal fit for clinicians

The Pharmaceutical Dilemma
Traceability and Validation, Margin
 Clinical Trials
 To assure outcomes, if processes aren’t soundly validated and traceable neither is
the drug
 Costs of missteps are astronomical
 R&D and Manufacturing
 Repeatable, traceable development, testing (Validation) and manufacturing
processes are vital
 Dispensation
 Validation of interaction rule sets (CDS) critical to assure patient outcomes and
drug efficacy and profit

Pharmaceutical Case Studies
 Cenduit
 Global provider of clinical trail services
 Specialize in Case Study software employing IRT (Interactive Response Technology) and Randomization
 Addition of SpiraTeam (replacing paper and excel) to manage trial requirements software development
cycle reduced release times by over 50% while significantly increasing process rigor and traceability
 Pfizer
 Multi-national drug and drug delivery support systems provider
 Optimizing technologies and branding to better-penetrate Acute Care market
 Working with client to design and validate drug interaction CDS in infusion pumps
 eHealth (Victoria, Australia)
 Developed reconciliation scheme for iSoft/Cerner/Pyxis integration
 Managed hundreds of thousands of transactions daily, built framework for global SNOMED/Multum
interface
 Allowed for drug traceability, accurate patient records and accountable and proficient CDS

Services
 Support
 Advanced technical support staffed by QAA and ALM experts
 Training
 Training for all Inflectra products
 Professional Services
 Specialized healthcare capabilities including HIS implementation guidance, patch and
regression support, BBV
 Broad Pharma and general Validation expertise
 Vertical-agnostic turnkey QA and ALM projects
 Design
 Implementation
 Augmentation
 Migration, off other platforms or manual processes
 Expert consulting on any aspect of QA, Performance Test or ALM projects

Q&A, Discussion

Contact Us
Scott Almeda
SmarteSoft
Main: +1 512.782.0403
Mobile: +1 603.866.0522

Challenges of Software Testing in the Life Sciences

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