Webinar: Transforming Healthcare QA with SpiraTeam - Achieving Excellence in Testing

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March 7th, 2018 – Adam Sandman

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2 | 6/29/2023 © Copyright 2006-2020 Inflectra Corporation
Agenda
 Challenges around Development & Testing in Healthcare
 Best practices in Software Requirements & Testing
 Overview of the Inflectra Platform
 SpiraTeam & SpiraPlan Compliance Features:
 Electronic Signatures
 End-to-End Traceability
 Audit Trails
 Risk Management [SpiraPlan]
 Q&A

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Challenges around Development
& Testing in Healthcare

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What are some of the top challenges?
 Whether developing medical devices, conducting medical
trials, managing patient data, or coordinating care,
compliance is critical.
 Health and life science industries are heavily regulated, and
the regulations are constantly changing.
 Companies constantly need to perform continuous testing
and validation, with real-time traceability.
 The current pandemic shows that you have be adaptable to
real-time needs, but maintain compliance

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What are some of the top challenges?
 Validation of all systems
 CFR Part 11 compliance
 Need to test all systems
 Need to test the testing systems!
 Drive for Agile Compliance
 New technologies let us develop new uses for existing systems,
devices and therapies
 To speed therapy, the rules are delayed not removed…
 How to be agile now and “compliant later”?

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Agile Today
Compliance Ready

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Best practices in
Software Validation & Testing

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General Best Practices (1)
 Avoid manual paper methods as much as possible
 Having to manually “glue” together different artifacts such as
Excel Spreadsheets and Word documents
 Easy to miss patterns and deficiencies
 Create an integrated process across your disciplines:
 Requirements > Testing and Quality
 Requirements > Development and Change Management
 Risk Management
 Documentation Management
 Have a single source of truth with integrated traceability

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General Best Practices (2)
 The source of “truth” should be the system
 Generate your documentation from the system
 Don’t let people work “around” the system
 Change the concept of requirements from being a document
to being a set of data that can be used to inform all other
activities.
 Ensure the system is configured to match your process
 Workflows, approvals and electronic signatures are key.

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Overview of the Inflectra
Platform
What Inflectra offers and how the different parts fit together

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Bridging Between Agile and Compliance
Support for Regulated Processes Modern, Agile Processes
• Baselining
• Risk Management
• Electronic Signatures
• Data Privacy
• Compliance
• Workflow
• Requirements Mgt
• On-Premise
• CI / CD
• Scrum
• Kanban
• Scaled Agile
• DevOps
• Distributed Teams
• Remote Working
• Cloud-Based

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Compliancewith International Standards
EudraLex
Volume4
PartI&II
GuidanceonData
Integrity

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SpiraPlan®
Agile Program & Portfolio Management
SpiraTeam®
Application Lifecycle Management (ALM)
Introducing the Inflectra® Suite
SpiraTest®
Requirements, Test Management
& Bug Tracking
KronoDesk®
IT Support & Help Desk
Rapise®
Test Automation (Web, GUI, Services)
TaraVault® - Source Code Management
SpiraCapture™
Exploratory Testing

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SpiraPlan – Enterprise Program
Management
SpiraPlan®
Agile Program & Portfolio Management
SpiraTeam®
Application Lifecycle Management (ALM)
SpiraTest®
Requirements, Test Management
& Bug Tracking
TaraVault® - SCM Using Git or Subversion
Enterprise
Project
Team
See Spira Comparison Matrix for a comparison on the different editions

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SpiraPlan Compliance Features
How we can help you streamline and automate your testing and
compliance.

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Regulated Industries - Automating
Compliance
End-to-end
traceability out
of the box
Data Privacy,
Security
baked in
Generate
Documentation
from data
Workflows &
Electronic
Signatures
Integration across
the software
value chain

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Healthcare & Life Sciences
 Electronic signatures for FDA 21 Part 11 compliance
 Secure hosting with support for HIPAA BAA agreements
 End to end traceability of requirements, tests, and code
 Validated platform where you control update cadence

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Requirements Management
Requirements management with end-to-end traceability

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Requirements & Test Validation

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Requirements Test Traceability

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Traceability To Other Artifacts
 End to end traceability

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Integrated Risk Management
Manage your hardware and software risks with full traceability

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Document Management
Complete integrated document management system with
versioning, check-in/out and approval workflows.

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Workflow & Electronic Signatures

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Source Code Management
For software medical systems, traceability to the code
&

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Defect and Incident Tracking
Integrated defect tracking to track issues and corrections

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Audit Logging & Trail

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Controlled / Secure Access

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Federated Security with OAUTH and LDAP
• LDAP / Active Directory for On-Premise Customers
• OAUTH / ADFS for Cloud Customers

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Agile When You Need It…

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Resources to Help
How we can help you streamline and automate your testing and
compliance.

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Validation Resources
 Inflectra can supply a standard validation package for Spira
 Resources available for configuring Spira ‘in-place’
 HIPAA - https://www.inflectra.com/Ideas/Whitepaper/SpiraTeam-
HIPAA-Compliance-Checklist.aspx
 21 CFR Part 11 - https://www.inflectra.com/Ideas/Whitepaper/FDA-
Validation-and-Testing-with-21-CFR-Part-11.aspx
 GAMP moving from CSV to CSA -
https://www.inflectra.com/Ideas/Entry/preparing-gamp-computer-
software-assurance-csa-1434.aspx
 Cloud platform supports ability to lock “version”

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Validation Partners

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Application Demo

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